•起止时间：2015年财年（2014年10月1日至2015年9月30日）

王老吉

与药品有关的现场检查，有483缺陷的总计678次 其中与211有关的缺陷简述、详述、频率以及具体条款，(时间仓促，未翻译为中文，各位见谅！)见下表 机构人员

211条款	简述	详述	频率
211.22(d)	Procedures not  in writing, fully followed	The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].  Specifically, ***	160
211.25(a)	Training--operations, GMPs, written procedures	Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations].  Specifically, ***	50
211.25(a)	Training , Education , Experience overall	Employees  engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.  Specifically, ***	37
211.28(a)	Clothing appropriate for duties performed	Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not  appropriate for the duties they perform.  Specifically, ***	33
211.22(a)	Lack of quality control unit	There is no quality control unit.  Specifically, ***	27
211.28(a)	Protective Apparel Not Worn	Protective apparel is not worn as necessary to protect drug products from contamination.  Specifically, ***	25
211.22(c)	Approve or reject procedures or specs	The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products.  Specifically, ***	19
211.25(a)	GMP Training Frequency	GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them.  Specifically, ***	19
211.22(a)	Authority lacking to review records, investigate errors	The quality control unit lacks authority  to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred].  Specifically, ***	13
211.22(a)	Approve or reject components, products	The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug product containers] [closures] [in process materials] [packaging material] [labeling] [drug products].  Specifically, ***	9
211.22(b)	Adequate lab facilities not available	Adequate lab facilities for testing and approval or rejection of [components] [drug product containers] [closures] [packaging materials] [in-process materials] [drug products] are not available to the quality control unit.  Specifically, ***	6
211.25(c)	Inadequate number of  personnel	The number of qualified  personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***	6
211.25(b)	Supervisor Training/Education/Experience	Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the  [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, i	5
211.28(b)	Habits of good sanitation & health	Production personnel were not practicing good sanitation and health habits.  Specifically, ***	4
211.22(a)	Contract drug products--lack of responsibility	The quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under contract by another company.  Specifically, ***	3
211.28(c)	Unauthorized Personnel in Limited Access Areas	Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas.  Specifically, ***	2
211.34	Consultant Records	Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided].  Specifically, ***	2
211.28(d)	Excluding Employees with Illness, Lesions	Employees with [apparent illness] [open lesions] are not excluded from direct contact with [components] [drug product containers] [closures] [in-process materials] [drug products] until the condition is [corrected] [determined by competent medical personn	1

厂房设施

211条款	简述	详述	频率
211.42(c)(10)(iv)	Environmental Monitoring System	Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, ***	83
211.42(c)(10)(v)	Cleaning System	Aseptic processing areas are deficient regarding the system for cleaning  and disinfecting the [room] [equipment] to produce aseptic conditions.  Specifically, ***	60
211.42(c)	Defined areas of adequate size for operations	The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***	26
211.58	Buildings not maintained in good state of repair	Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair.  Specifically, ***	25
211.42(c)(10)(iii)	Air Supply	Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.  Specifically, ***	21
211.42(c)(10)(vi)	Equipment to control conditions	Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.  Specifically, ***	21
211.56(a)	Sanitation--buildings not clean, free of infestation	Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin]. Specifically, ***	18
211.46(b)	Equipment for Environmental Control	Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.  Specifically, ***	14
211.42(a)	Buildings of Suitable Size, Construction, Location	Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations.  Specifically, ***	13
211.42(b)	Product flow through building is inadequate	The flow  of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination.  Specifically, ***	10
211.42(c)(10)	Aseptic Processing Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.  Specifically,***	10
211.56(b)	Written sanitation procedures lacking	There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing in sufficient detail the methods, equipment and materials to be used] for sanitation.  Specifically, ***	8
211.52	Washing and toilet facilities are deficient	Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness].  Specifically, ***	6
211.42(b)	Adequate space lacking  to prevent mix-ups and contamination	The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components] [drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination.	5
211.56(b)	Written sanitation procedures not followed	Written procedures for sanitation are not followed.  Specifically, ***	5
211.42(c)(10)(i)	Floors, walls, ceiling surfaces	Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,***	3
211.56(c)	Written procedures lacking for use of pesticides etc.	Written procedures are lacking for the use of  [rodenticides] [insecticides] [fungicides] [fumigating agents] [cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components] [drug product containers] [closures] [packagin	3
211.42(c)(10)(ii)	Temperature / Humidity Controls	Aseptic processing areas are deficient regarding [temperature] [humidity]  controls.  Specifically, ***	2
211.42(c)(2)	Rejected Material Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition.  Specifically,***	2
211.42(c)(4)	In-Process Material Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.  Specifically, ***	2
211.42(c)(5)	Mfg / Processing Operations Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.  Specifically, ***	2
211.42(d)	Penicillin processing area not  kept separate	The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for other drug products for human use.  Specifically,  ***	2
211.46(c)	Exhaust systems inadequate to control air contamination	Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.  Specifically, ***	2
211.42(c)(1)	Incoming material area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, te	1
211.42(c)(6)	Pkg / Labeling Operations Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding the packaging and labeling operations. Specifically, ***	1
211.42(c)(7)	Quarantined Drug Products Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.  Specifically, ***	1
211.46(c)	Air filtration system lacking in production area	The production area air supply lacks an appropriate air filtration system.  Specifically, ***	1
211.46(d)	Penicillin air handling systems not kept separate	Air-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely separate  from those for other drug products for human use.  Specifically, ***	1
211.48(a)	Plumbing System Defects	The plumbing system contains defects that could contribute to the  contamination of drug products.  Specifically, ***	1
211.48(b)	Drains--Size, Back-siphonage Prevention	Drains are not [of adequate size] [provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer].  Specifically, ***	1

设备

211条款	简述	详述	频率
211.67(a)	Cleaning / Sanitizing / Maintenance	Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to  prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product.  Specifically, ***	68
211.68(a)	Calibration/Inspection/Checking not done	Routine [calibration] [inspection] [checking] of  [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance.  Specifically, ***	64
211.63	Equipment Design, Size and Location	Equipment used in the manufacture, processing, packing or holding of  drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance].  Specifically, ***	56
211.67(b)	Written procedures not established/followed	Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.  Specifically, ***	53
211.68(b)	Computer control of master formula records	Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.  Specifically, ***	35
211.67(b)	Written procedures fail to include	Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the method	25
211.67(c)	Cleaning/maintenance records not kept	Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.  Specifically, ***	15
211.68(b)	input/output verification	Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy.  Specifically, ***	9
211.68(a)	Written calibration / inspection records not  kept	Records of the [calibration checks] [inspections] of  automatic, mechanical or electronic equipment, including computers or related systems are not maintained.  Specifically, ***	8
211.68(b)	Backup data not assured as exact and complete	Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems.  Specifically, ***	4
211.67(b)(2)	Cleaning SOPs/schedules	Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.  Specifically, ***	3
211.67(b)(3)	Cleaning SOPs/instructions	Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necess	3
211.67(b)(1)	Cleaning SOP/responsibility	Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.  Specifically, ***	2
211.67(b)(6)	Cleaning SOP/inspection	Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.  Specifically, ***	2
211.65(a)	Equipment construction - reactive surfaces	Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established require	1
211.65(b)	Substances That Come in Contact	Substances required for equipment operations such as lubricants and coolants come in contact with [components] [drug product containers] [closures] [in-process materials] [drug product] so as to alter the safety, identity, strength, quality or purity of t	1
211.67(b)(4)	Cleaning SOPs/equipment identification	Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification.  Specifically, ***	1
211.68(b)	Written record not kept of program and validation data	A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.  Specifically, ***	1

原辅料、药品容器及封闭物

211条款	简述	详述	频率
211.84(d)(2)	Reports of Analysis (Components)	Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliabilit	33
211.84(d)(1)	Identity Testing of Each Component	The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.  Specifically, ***	25
211.80(a)	Written Procedures Not Followed	Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].  Specifically, ***	16
211.80(a)	Procedures To Be in Writing	Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].  Specifically, ***	15
211.84(a)	Components withheld from use pending release	Each lot of [components] [drug product containers] [closures] is not withheld  from use until the lot has been sampled, tested, examined, and released by the quality control unit.  Specifically, ***	14
211.80(b)	Handling and Storage to Prevent Contamination	There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination.  Specifically, ***	13
211.84(d)(2)	Testing Each Component for Conformity with Specs	Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically, ***	13
211.84(b)	Representative Samples	Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination.  Specifically, ***	9
211.87	Retest of approved components/containers/closures	Approved [components] [drug product containers] [closures] are not retested or reexamined as appropriate for identity, strength, quality and purity after [storage for long periods] [exposure to conditions that might have an adverse effect]  with subsequen	9
211.94(b)	Protection from external factors	Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.  Specifically, ***	8
211.84(d)(2)	Establish reliability of supplier's C of A	Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.  Specifically, ***	6
211.84(d)(6)	Microbiological Contamination Exam	Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.  Specifically, ***	6
211.94(c)	Containers & Closures Clean, Sterilized, Pyrogen-free	Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use.  Specifically, ***	6
211.84(e)	Rejecting  When Specifications Not Met	Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for identity, strength, quality, and purity.  Specifically, ***	5
211.94(a)	Reactive/Additive/Absorptive Containers/Closures	Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.  Specifically, ***	5
211.80(d)	Status of Each Lot Identified	Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined, approved or rejected.  Specifically, ***	4
211.84(d)(1)	Component identity verification	Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.  Specifically,***	4
211.84(d)(2)	Component identification test	Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.  Specifically, ***	4
211.84(d)(3)	Testing Containers & Closures Conformity with Specs	Containers and closures are not tested for conformance with all appropriate written procedures.  Specifically, ***	4
211.84(d)(6)	Objectionable microbiological contamination	Each lot of a [component] [drug product containers] [closures] liable to objectionable  microbiological contamination is deficiently subjected to microbiological tests before use.  Specifically,  ***	4
211.89	Quarantine of Rejected Components et. al.	Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.  Specifically, ***	4
211.82(b)	Quarantine Storage of Components	Incoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as appropriate, and released.  Specifically, ***	3
211.84(b)	Representative Samples Criteria	The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria.  Specifically, ***	3
211.84(d)(2)	Component written specification	Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically,  ***	3
211.94(d)	Written Procedures to Remove Pyrogens	There are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilization] [methods of processing] to remove pyrogenic properties.  Specifically, ***	3
211.80(d)	Identification of Each Lot in Each Shipment	Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components] [drug product containers] [closures].  Specifically, ***	2
211.80(c)	Storage off Floor, Spaced Suitably	Bagged or boxed components of drug product [containers] [closures] are not [stored off the floor] [suitably spaced to allow cleaning and inspection].  Specifically, ***	1
211.84(c)(2)	Containers sampled so as to prevent contamination	Containers are not [opened] [sampled] [resealed] in a manner designed to prevent contamination of [their contents] [other components] [other drug product containers or closures].  Specifically, ***	1
211.84(c)(4)	Compositing of Sub Samples	Components which must be sampled from top, middle and bottom of the container are not kept separate, but instead are composited for testing.  Specifically, ***	1

生产及工艺控制

211条款	简述	详述	频率
211.113(b)	Procedures for sterile drug products	Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].  Specifically, ***	104
211.100(a)	Absence of Written Procedures	There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.  Specifically, ***	95
211.110(a)	Control procedures to monitor and validate performance	Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.  Specifically	69
211.113(b)	Validation lacking for sterile drug products	Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include [adequate] validation of the sterilization process.  Specifically, ***	53
211.100(b)	SOPs not followed / documented	Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance].  Specifically, ***	52
211.111	Establishment of time limitations	Time limits are not established when appropriate  for the completion of each production phase to assure the quality of the drug product.  Specifically, ***	27
211.113(a)	Procedures for non-sterile drug products	Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed].  Specifically, ***	21
211.100(b)	Procedure Deviations Recorded and Justified	Deviations from written production and process control procedures are not [recorded] [justified].  Specifically, ***	20
211.100(a)	Changes to Procedures Not Reviewed, Approved	Changes to written procedures are  not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, ***	19
211.103	Actual vs. theoretical yields not determined	Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of [manufacturing] [processing] [packaging] [holding] of the drug product.  Specifically, ***	13
211.110(a)	Written in-process control procedures	Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on appropriate samples of in-process materials of each batch.  Specifically, ***	11
211.100(a)	Approval and review of procedures	Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit].  Specifically, ***	9
211.110(c)	In-process materials characteristics testing	In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the quality control unit [during the production process] [after storage for long periods]. Specifically, ***	5
211.101(d)	Component addition checked by 2nd person	Each component is not added to a batch by one person and verified by a second person.  Specifically, ***	4
211.105(a)	Identification of containers, lines, equipment	All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase of processing of the batch].  Specifically, ***	4
211.105(b)	Distinctive ID or code not recorded in batch record	The batch records do not record the distinctive [identification number] [code] [name of equipment]  to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.  Specifically, ***	4
211.110(b)	In-process materials specifications	In-process specifications are not [consistent with drug product final specifications] [derived from previous acceptable process average and process variability estimates where possible] [determined by the application of suitable statistical procedures whe	4
211.111	Deviations of production time limits	Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product].  Specifically, ***	4
211.101(a)	Batches Formulated to less than 100%	Written production and control procedures  include batches formulated with the intent to provide less than  100 percent of the labeled or established amount of active ingredient.  Specifically, ***	3
211.101(b)	Identification of new containers	For components removed from the original containers, the new container fails to be identified with [component name or item code] [receiving or control number] [weight or measure] [batch for which component was dispensed including product name, strength an	3
211.110(b)	In-process materials specifications testing	Examination and testing of samples is not done to assure that in-process materials conform to specifications.  Specifically, ***	3
211.115(a)	Reprocessing procedures not written or followed	Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are  not [written] [followed].  Specifically, ***	3
211.115(a)	Reprocessing procedures lack steps to be taken	Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.  Specifically, ***	3
211.101(d)	Component release checked by 2nd person	Each container of component dispensed to manufacturing is not examined by a second person to assure that [the component was released by the quality control unit] [the weight or measure is correct as stated in the batch records] [the containers are properl	2
211.110(a)	Control procedures fail to include the following	Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions].  Specifically,***	2
211.110(a)(5)	Solution clarity, completeness, pH	The in-process control procedures were deficient in that they did not include an examination of the [clarity] [completeness] [pH] of solutions.  Specifically, ***	2
211.101(b)	Measured components for manufacturing	Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].  Specifically, ***	1
211.101(c)	Weighing/measuring/subdividing supervision	Component [weighing] [measuring] [subdividing] operations are not adequately supervised.  Specifically, ***	1
211.101(d)	Verification of component addition	Each component is not added to the batch by one person and verified by a second person..  Specifically, ***	1
211.103	Yield calculations not verified by 2nd person	Yield calculations are not performed by one person and independently verified by a second person.  Specifically, ***	1
211.110(a)(3)	Mixing adequacy	The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.  Specifically, ***	1
211.110(d)	Rejected in-process materials not quarantined	Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable.  Specifically, ***	1
211.115(b)	Reprocessing/quality control unit	Reprocessing  was  performed without the [review] [approval] of the quality control unit.  Specifically, ***	1

包装及标签控制

211条款	简述	详述	频率
211.137(a)	Expiration date lacking	Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.  Specifically, ***	26
211.125(a)	Strict control not exercised over labeling issued	Strict control is not exercised over labeling issued for use in drug product labeling operations.  Specifically, ***	13
211.125(f)	Procedures Written and Followed	Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***	11
211.130	Procedures are written, and followed	Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed].  Specifically, ***	9
211.122(a)	Written procedures describing in detail	There is a lack of written  procedures describing in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of labeling and packaging materials.  Specifically, ***	8
211.122(d)	Label storage access limited to authorized personnel	Access to the storage area for labels and labeling materials is not limited to authorized personnel.  Specifically, ***	5
211.130(e)	Packaging line inspection before use	Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all drug products have been removed from previous operations.  Specifically, ***	4
211.134(b)	Representative samples after completion	Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations.  Specifically, ***	4
211.130(c)	Lot or control number assigned	The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.  Specifically, ***	3
211.122(a)	Sampling/testing of labeling/packaging materials	Labeling and packaging materials are not  [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product.  Specifically, ***	2
211.122(a)	Written procedures not followed	Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed.  Specifically, ***	2
211.125(c)	Label reconciliation discrepancies evaluation/investigation	Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated].  Specifically, ***	2
211.130(a)	Prevention of cross contamination, mix-ups	There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.  Specifically, ***	2
211.130(b)	Unlabeled filled containers controls	Filled drug product containers which are set aside and held in an unlabeled condition are not [identified] [handled] to preclude mislabeling of individual containers, lots or portions of lots.  Specifically, ***	2
211.130(e)	Packaging line inspection documentation	Results of inspection of packaging and labeling facilities are not documented in the batch production records.  Specifically, ***	2
211.134(a)	Correct labels during finishing operations	Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.  Specifically, ***	2
211.122(b)	Labeling and packaging improperly approved/released	Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use].  Specifically, ***	1
211.122(g)	Failure to include one of special control procedures	Packaging and labeling operations involving the use of cut labels fail to include one of the three special control procedures provided for in the regulations ( e.g., dedicated lines, automated equipment for 100% exam, visual inspection for 100% exam).  Sp	1
211.122(g)(2)	Electronic or electromechanical equipment	The packaging and labeling operation for cut labels which relies on the use of electronic or electromechanical equipment does not provide for 100-percent examination for correct labeling [during] [after completion of] finishing operations.  Specifically,	1
211.122(g)(3)	Visual inspection	The packaging and labeling operation involving cut labels and relying on visual inspection does not provide for [100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling] [examination to be	1
211.125(e)	Return of  labeling	Returned labeling is not maintained and stored in a manner to [prevent mix-ups] [provide proper identification].  Specifically, ***	1
211.130(d)	Examination of packaging and labeling	Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records].  Specifically, ***	1
211.132(b)	Tamper-evident feature to remain intact	The tamper-evident feature [is not designed to] [does not] remain intact when  handled in a reasonable manner during [manufacture] [distribution] [retail display].  Specifically, ***	1
211.132(b)(1)	OTC products requiring tamper-evident packaging	OTC products packaged for retail sale which are not specifically excluded from the requirement for tamper-evident packaging are not sold in tamper-evident packages.  Specifically, ***	1
211.132(b)(1)	Hard gelatin capsules	The packaging of hard gelatin capsules which are not sealed by tamper resistant technology does not include two tamper resistant packaging features.  Specifically, ***	1
211.132(b)(2)	Gelatin capsules requiring tamper-evident technology	Two-piece, hard gelatin capsules (OTC) are not sealed using an acceptable tamper-evident technology.  Specifically, ***	1
211.132(c)	Tamper evident-labeling requirement	OTC products packaged for retail sale which are not specifically excluded from the requirement for tamper-evident packaging do not bear a prominently-placed statement on the package which [identifies all tamper-evident features] [identifies capsule sealin	1
211.134(c)	Examinations documented	The results of the examination of the packaged and labeled products were not documented in the batch production or control records.  Specifically, ***	1

贮存及销售

211条款	简述	详述	频率
211.142(b)	Storage under appropriate conditions	Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected.  Specifically, ***	21
211.142	Written warehousing procedures established/followed	Procedures describing the warehousing of drug products are not [established] [followed].  Specifically, ***	15
211.150(b)	Distribution Recall System	The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.  Specifically,  ***	8
211.142(a)	Quarantine - actual practice	Drug products are not quarantined before being released by the quality control unit.  Specifically, ***	4
211.150	Written distribution procedure	Written distribution procedures are not [established] [followed].  Specifically, ***	4
211.150(b)	Recall facilitation	A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.  Specifically, ***	4
211.150(a)	Distribution of oldest approved drugs	The oldest approved stock of drug products are not distributed first and there is no justification for this practice.  Specifically,  ***	2
211.142(a)	Quarantine - written procedures	Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit.  Specifically, ***	1
211.150(a)	Distribution of oldest stock first	Distribution procedures do not include a procedure whereby the oldest approved stock of a drug product is distributed first.  Specifically, ***	1

实验室控制

211条款	简述	详述	频率
211.160(b)	Scientifically sound laboratory controls	Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [	130
211.165(a)	Testing and release for distribution	Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release.  Specifically, ***	80
211.166(a)	Lack of written stability program	There is no written testing program designed to assess the stability characteristics of drug products.  Specifically, ***	63
211.160(a)	Following/documenting laboratory controls	Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance].  Specifically, ***	40
211.165(e)	Test methods	The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  Specifically, ***	33
211.167(a)	Sterility/pyrogen-free testing	Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements.  Specifically, ***	33
211.160(b)(4)	Calibration - at intervals, written program, remedial action	The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met]	30
211.160(a)	Lab controls established, including changes	The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit	27
211.166(a)	Written program not followed	The written stability testing program is not followed.  Specifically, ***	20
211.166(a)(3)	Valid stability test methods	The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods.  Specifically, ***	20
211.170(b)	Annual visual exams of drug products	Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.  Specifically, ***	17
211.165(b)	Microbiological testing	Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.  Specifically, ***	16
211.165(f)	Failing drug products not rejected	Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected.  Specifically, ***	15
211.167(a)	Sterility/pyrogens - test methods written, followed	Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed].  Specifically, ***	12
211.160(a)	Deviations from laboratory control requirements	Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified].  Specifically, ***	11
211.160(b)(4)	Establishment of calibration procedures	Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed].  Specifically, ***	9
211.165(d)	Acceptance criteria for sampling & testing	Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet [each appropriate specification] [appropriate statistical quality control criteria] as a condition for thei	9
211.166(a)	Results not used for expiration dates, storage cond.	Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].  Specifically, ***	9
211.160(b)(3)	Drug products - samples representative, identified properly	Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified].  Specifically, ***	8
211.166(b)	Adequate number of batches on stability	An adequate number of batches of each drug product are not tested [nor are records of such data maintained] to determine an appropriate expiration date.  Specifically, ***	8
211.160(b)(4)	Instruments, apparatus, et. al. not meeting specs	The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed.   Specifically, ***	7
211.160(b)(1)	Incoming lots - conformance to written specs-	Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products	6
211.160(b)(1)	Sampling and testing procedures described	Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used.  Specifically, ***	6
211.170(b)	Reserve samples identified, representative, stored	Reserve drug product samples  are not [appropriately identified] [representative of each lot or batch of drug product] [retained and stored under conditions consistent with product labeling].  Specifically, ***	6
211.160(b)(2)	In-process samples representative, identified properly	Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified].  Specifically, ***	5
211.160(b)(4)	Written calibration procedures	Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for remedial action if limits are not met]	5
211.166(a)(4)	Testing in same container - closure system	The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.  Specifically, ***	5
211.165(c)	Sampling and testing plans not followed	Written procedures for sampling and testing plans are not followed for each drug product.  Specifically, ***	4
211.166(a)(2)	Stability sample storage conditions described	The written stability program for drug products does not describe the storage conditions for samples retained for testing.  Specifically, ***	4
211.166(b)	Accelerated stability studies	Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not  supported with ongoing full shelf life studies.  Specifically, ***	4
211.170(b)	Drug product reserve containers	Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product].  Specifically, ***	4
211.160(b)(3)	Drug products-sampling procedures/specifications	Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products.  Specifically, ***	3
211.166(a)(1)	Sample size - test intervals	The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability.  Specifically, ***	3
211.166(c)(1)	Homeopathic drugs, assessment of stability	There is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradati	3
211.176	Failing to test for penicillin cross-contamination	Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.  Specifically, ***	3
211.160(b)(1)	Samples (various types) representative, identified properly	Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not [representative] [adequately identified].  Specificall	2
211.160(b)(3)	Acceptance of drug products	Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products.  Specifically, ***	2
211.165(c)	Sampling and testing plans not described	Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested].  Specifically, ***	2
211.166(a)(5)	Testing of reconstituted drugs	The written stability program does not include testing  of  drug products for reconstitution [at time of dispensing - as directed in the labeling] [after they are reconstituted].  Specifically, ***	2
211.170(a)	Active ingredient retained sample kept	A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained].   Specifically, ***	2
211.160(b)(2)	Acceptance of in-process materials	Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for in-process materials.  Specifically, ***	1
211.160(b)(3)	Drug product sample	Drug product samples are not [representative of the entire batch] [properly identified].  Specifically, ***	1
211.160(b)(4)	Test devices not meeting specifications	Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used.  Specifically, ***	1
211.165(d)	Acceptance/Rejection Levels	The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].  Specifically, ***	1
211.166(b)	Tentative expiration date	Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no [stability studies] [drug product testing at appropriate intervals] conducted until the tentative expir	1
211.167(b)	Ophthalmic ointments - testing for foreign particles	Each batch of ophthalmic ointment is not appropriately  tested to determine conformance to specifications regarding the presence of [foreign particles] [harsh or abrasive substances].  Specifically, ***	1
211.167(b)	Ophthalmic ointments -test methods written, followed	Test procedures for ophthalmic ointments are not [written] [followed].  Specifically, ***	1
211.167(c)	Controlled release dosage form testing	Each batch  of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient.  Specifically, ***	1
211.167(c)	Controlled release test methods written, followed	Test procedures describing the testing of controlled release dosage form drug product are not [written] [followed].  Specifically, ***	1
211.170(b)	Reserve drug product sample quantity - all tests	The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product.  Specifically, ***	1
211.170(b)(1)	Reserve sample retention time	The retention period for drug product reserve samples (except those described in 211.170(b)(2) and (3)) is deficient in that they are not retained for one year after the expiration date of the drug product.  Specifically, ***	1
211.170(b)(1)	Retention time of reserve samples, in general	Reserve samples for drug products are not retained for one year after the expiration date of the drug product.  Specifically, ***	1
211.176	Marketing of drug products with penicillin levels	Marketing of drug products which contain detectable levels of penicillin occurred, when tested according to FDA-approved procedures for detecting and measuring penicillin contamination in drugs.  Specifically, ***	1

记录和报告

211条款	简述	详述	频率
211.192	Investigations of discrepancies, failures	There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed.  Specifically, ***	124
211.188	Prepared for each batch, include complete information	Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch].  Specifically, ***	56
211.192	Written record of investigation incomplete	Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do not [always] include the conclusions and follow-up.  Specifically, ***	47
211.198(a)	Complaint Handling Procedure	Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed].  Specifically, ***	40
211.194(a)	Complete test data included in records	Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.  Specifically, , ***	39
211.180(e)(2)	Items to cover on annual reviews	Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product].  Specifically	37
211.192	No written record of investigation	Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications].  Specifically, ***	30
211.192	Quality control unit review of records	Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.  Specifically, ***	27
211.192	Extent of discrepancy, failure  investigations	Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications]  did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specif	22
211.198(a)	Procedures to be written and followed	Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed].  Specifically, ***	20
211.180(e)(1)	Review of representative number of batches	Written procedures are not [established] [followed] for  evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.  Specifically, ***	19
211.182	Written records kept in individual logs	Written records of major equipment [cleaning] [maintenance] [use]  are not included in individual equipment logs.  Specifically, ***	15
211.186(b)(9)	Manufacturing Instructions and Specifications	The master production and control records are deficient in that they do not include complete [manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special notations] [precautions].  Specifically, ***	13
211.186(b)(9)	Complete instructions, procedures, specifications et. al.	Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed].  Specifically, ***	13
211.180(e)	Records reviewed annually	Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.  Specifically, ***	12
211.188(b)(8)	Labeling control records including specimens or copies	Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.  Specifically, ***	12
211.194(a)(8)	Second person sign off	Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for [accuracy] [completeness] [compliance with established standards].  Specifically, ***	12
211.198(b)(2)	Complaint Investigation/Follow-Up Findings	Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].  Specifically, ***	12
211.186(a)	Written procedures followed	Procedures for the preparation of master production and control records are not [described in a written procedure] [followed].  Specifically, ***	10
211.194(a)(4)	Data secured in course of each test	Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [c	9
211.188(b)	Batch production and Batch Control Record Requirements	The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding].  Specifically, ***	7
211.188(b)(8)	Labeling Control Records and Label Copies	The batch production and control records are deficient in that they do not  include [complete labeling control records] [specimen] [copy] of labeling.  Specifically, ***	7
211.194(a)(2)	Suitability of testing methods verified	The suitability of all testing methods is not verified under actual conditions of use.  Specifically, ***	7
211.194(d)	Laboratory equipment calibration records	Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].  Specifically, ***	6
211.194(c)	Testing and standardization of standards et. al.	Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions].  Specifically, ***	5
211.198(a)	Adverse Drug Experience	Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent [serious] [unexpected adverse drug experiences] which are required to be reported to FDA. Specifically, ***	5
211.198(a)	Reporting of adverse drug experience to FDA	Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food	5
211.198(a)	Complaints reviewed by Quality Control Unit	Written procedures describing the handling of complaints do not include provisions for [review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications] [a determination as to the need	5
211.198(b)	Maintenance of Complaint File	Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.  Specifically, ***	5
211.198(b)(1)	Complaint Record required information	Complaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].  Specifically, ***	5
211.180(b)	Record maintenance 1 year (except exempt OTC)	All records of  [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product are not maintained at least one (1) year after the expiration date.  Specifically, ***	4
211.180(e)(2)	Review of problem drugs	The procedures for the annual quality standards record evaluation are deficient in that they do not  address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation] records for each drug product.  Specifically, ***	4
211.186(a)	Signature and checking of records -- 2 persons	The master production and control records for each batch size of drug product are not  [prepared, dated, and signed by one person with a full handwritten signature] [independently checked, dated, and signed by a second person].  Specifically, ***	4
211.194(a)(1)	Sample identification and other information	Laboratory records do not include [a description of the sample received for testing] [the source or location from where the sample was obtained] [the quantity of the sample] [the lot number or other distinctive code of the sample] [the date the sample was	4
211.194(a)(4)	Complete Test Data	Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.  Specifically, ***	4
211.194(a)(5)	Calculations performed are in the records	Laboratory records do not include a record of all calculations performed in connection with the test.  Specifically, ***	4
211.194(a)(6)	Test results, comparison with standards not included	Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug prod	4
211.198(b)	Written complaint record  to be maintained at facility	A written record of each complaint is not maintained in a file designated for drug product complaints [at the facility where the drug product was manufactured, processed or packed] [at a facility other than the facility in which the drug product was manuf	4
211.198(b)(2)	Written record of complaint to include findings, follow-up	Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up].  Specifically, ***	4
211.182	Personnel  dating/signing equipment log	The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log.  Specifically, ***	3
211.186(b)(7)	Theoretical Yield and Percentages	The master production and control records are deficient in that they do not include a statement of theoretical yield and [minimum] [maximum] [yield percentages].  Specifically, ***	3
211.188(a)	Accurate reproduction included	Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was  checked for accuracy, dated and signed.  Specifically, ***	3
211.188(b)(3)	Identification of each  component or in-process material	Batch production and control records do not include the specific identification of each batch of [component] [in-process material] used for each batch of drug product produced.  Specifically, ***	3
211.188(b)(12)	Investigations made into any unexplained discrepancy	Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.  Specifically, ***	3
211.188(b)(7)	Documentation of Actual Yield and Theoretical Yield	The batch production and control records are deficient in that they do not  include a statement of the [actual yield] [percentage of theoretical yield].  Specifically, ***	3
211.188(b)(9)	Description of containers and closures	Batch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product produced.  Specifically, ***	3
211.194(a)(2)	Statement of methods and data	Laboratory records do not include a statement of [each method used in the testing of a sample] [the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the prod	3
211.194(b)	Test method modification records not maintained	Complete records are not maintained of any modification of an established method employed in testing.  Specifically, ***	3
211.196	Distribution Record Requirements	Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product].  Specifically, ***	3
211.198(a)	Quality Control Review	Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit.  Specifically, ***	3
211.198(b)(3)	Determination not to conduct investigation of complaint	The written record did not include the [reason an investigation was found not to be necessary] [name of the responsible person making the determination not to conduct an investigation] when an investigation into [unexplained discrepancies] [the failure of	3
211.180(c)	Records not made readily available to FDA	Records associated with drug product [components] [containers] [closures] [labeling] [production] [control] [distribution] and within the retention period for such records, were not made readily available for authorized inspection.  Specifically, ***	2
211.182	Specific information required in individual logs	Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].  Specifically, ***	2
211.184(b)	Component Test Records	The [component] [drug product container] [closure] [labeling] records do not include the [results of tests or examinations performed] [the conclusions derived from tests or examinations performed].  Specifically, ***	2
211.184(d)	Labeling: documentation of exam and review	There is no documentation of the examination and review of labels and labeling for conformity with [established specifications] [the assigning of a lot or control number].  Specifically, ***	2
211.186(b)(7)	Theoretical yield statement including percentages	Master production and control records lack a statement of theoretical yield [including the maximum and minimum percentages of theoretical yield beyond which investigation is required].  Specifically, ***	2
211.188(b)(11)	Identification of Persons Performing Significant Steps	The batch production and control records are deficient in that they do not include identification of persons [performing] [supervising] [checking] each significant step in the operation.  Specifically, ***	2
211.188(b)(11)	Identification of persons involved, each significant step	Batch production and control records do not include the identification of the persons [performing] [directly supervising] [checking] each significant step in the operation, for each batch of drug product produced.  Specifically, ***	2
211.188(b)(4)	Weights and measures of components used	Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced.  Specifically, ***	2
211.188(b)(5)	In-process and laboratory control results	Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced.  Specifically, ***	2
211.194(a)(7)	Signatures and dates--person who performs test	Laboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed].  Specifically, ***	2
211.194(b)	Test method modification records do not  include	Records maintained of any modification of an established method employed in testing do not include [the reason for the modification] [the data to verify that the modification produced results that are at least as accurate and reliable for the material bei	2
211.198(b)(1)	Written complaint record must include	Written complaint records do not include, where known, [the name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].  Specifically, ***	2
211.180(e)(1)	Representative Number of Batches for Annual Review	The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of  [approved] [rejected] batches.  Specifically, ***	1
211.182	Dedicated equipment: records part of batch record	The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record.  Specifically, ***	1
211.182	Chronological Order of Equipment Log Entries	The entries in the equipment cleaning and use logs are not in chronological order.  Specifically, ***	1
211.184(a)	Record information required	The records for [components] [drug product containers or closures] [labeling]  do not include the [identity and quantity of each shipment of each lot] [name of the supplier] [supplier's lot number]  [receiving code] [date of receipt] [name of the prime ma	1
211.184(c)	Individual inventory record	Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associated  batch or lot of	1
211.184(e)	Records of disposition of rejected material	Records do not include the disposition of rejected [components] [drug product containers] [closures] [labeling].  Specifically, ***	1
211.186(b)(4)	Variation in the Amount of Components Used	The master production and control records are deficient in that they lack a justification for the variation in the amount of components used in the preparation of a dosage form.  Specifically, ***	1
211.186(b)(8)	Description of containers, labels, et. al.	Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible fo	1
211.188(a)	Accurate reproduction	The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or control record] [checked for accuracy, dated, and signed].  Specifically, ***	1
211.188(b)(10)	Records of any sampling performed	Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced.  Specifically, ***	1
211.188(b)(13)	Results of drug product inspections and examinations	The batch production and control records are deficient in that they do not include results of drug product [examinations] [inspections].  Specifically, ***	1
211.188(b)(2)	Identity of major equipment and lines used	Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced.  Specifically, ***	1
211.188(b)(3)	Identification of Components and In-Process Materials	The batch production and control records are deficient in that they do not include specific identification of each [batch of component] [in-process material] used.  Specifically, ***	1
211.188(b)(6)	Documentation of Packaging and Labeling Area Inspections	The batch production and control records are deficient in that they do not  include documentation of the inspection of the [packaging] [labeling] area before and after use.  Specifically, ***	1
211.188(b)(7)	Actual yield, % of theoretical yield	The batch production and control records do not include a statement of the [actual yield] [percentage of theoretical yield] at appropriate stages of processing for each batch of drug product produced.  Specifically, ***	1
211.194(a)(2)	Test methods ID and data location	Laboratory records are deficient in that they do not include [a statement of the method used in testing the sample] [the location of the data that assures the accuracy and reliability of the test method].  Specifically, ***	1
211.194(a)(2)	Laboratory Test Method Verification	Verification of the suitability of the testing methods is deficient in that they are not [performed under actual conditions of use] [documented on the laboratory records].  Specifically, ***	1
211.194(a)(2)	Reference and method not stated	Laboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized standard references] [an approved new drug application and the referenced method is not modified].  Specifically, ***	1
211.194(a)(3)	Weight or measure of sample	Laboratory records do not include a statement of the weight or measure of sample used for each test, where appropriate.  Specifically, ***	1
211.194(a)(7)	Identification of Person Performing the Testing	Laboratory records are deficient in that they do not include the [initials] [signature] of the person performing the tests and the dates the tests were performed.  Specifically, ***	1
211.194(a)(8)	Identification of Person Performing Review of Lab Records	Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy.  Specifically, ***	1
211.198(b)	Complaint File Location	Complaint procedures are deficient in that written complaint files are not maintained at the manufacturing site nor were they readily available from their off-site location.  Specifically, ***	1
211.198(b)	Retention time of complaints	Complaint procedures are deficient in that written complaint records are not maintained for [at least one (1) year after the expiration date of the drug product] [at least one (1) year after the date that the complaint was received].  Specifically, ***	1
211.198(b)	Retention time of OTC drug complaints	Complaint procedures are deficient in that complaint records are not maintained for OTC drugs, without an expiration date, for at least three (3) years after distribution of the drug product.  Specifically, ***	1
211.198(b)	Records maintained for 3 years (exempt OTC drugs)	Written complaint file records for OTC drugs lacking expiration dating because they meet the criteria for exemption, are not maintained for 3 years after distribution of the drug product.  Specifically, ***	1
211.198(b)	Records maintained for 1 year (except certain  OTC drugs)	Written complaint file records involving a drug product are not maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date the complaint was received, whichever is longer.  Specifically, ***	1
211.198(b)(2)	Complaint Record at Location of Investigation	Complaint records are deficient in that they are not maintained at the establishment where the investigation occurred.  Specifically, ***	1
211.198(b)(2)	Written investigation record or copy kept at establishment	The written record or copy of the record of an investigation of a complaint conducted in relation to [any unexplained discrepancy] [ the failure of a batch or any of its components to meet any of its specifications]  is not maintained at the establishment	1
211.198(b)(3)	Reason for Not Conducting Complaint Investigation	Complaint records are deficient in that they do not document the reason and the individual  making the decision not to conduct a complaint investigation.  Specifically, ***	1

药品退货及挽救处理

211条款	简述	详述	频率
211.204	Returned drug procedures in writing and followed	Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed].  Specifically, ***	7
211.204	Returned drug products identified and held	Returned drug products are not [identified as such] [held].  Specifically, ***	2
211.204	Record information inclusions	Records of returned drug products do not include the  [name] [labeled potency] [lot, control or batch number] [reason for return] [quantity] [date of disposition] [ultimate disposition].  Specifically, ***	1
211.204	Returned drug products with doubt cast as to safety et. al.	Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove th	1
211.204	Reprocessed returned drug products	Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity.  Specifically, ***	1
211.208	Salvaging performed without evidence	Salvaging operations  on drug products which may have been subjected to improper storage conditions proceeded  in the absence of evidence from [laboratory tests and assays to establish that the drug products meet all applicable standards of identity, stre	1