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发表于 2016-8-9 11:17:01
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9. Should laboratory glassware be included in a firm's equipment cleaning validation program?
No. FDA does not expect laboratory glassware to be included in the processing equipment cleaning validation program. Glassware must, of course, be clean, and CGMP regulations consider laboratory equipment to be included within the scope of 21 CFR 211.67. Cleanliness is best assessed by inspecting laboratory procedures for the following:
Use of nondedicated glassware and other equipment
Method validation (e.g., ruggedness)
Absence of extraneous or interfering data in the results of sample analyses
Laboratory cleaning procedures may include repetitive rinses with the solvent used to prepare the analyte, followed by oven drying. The equipment need not be swabbed or otherwise tested to ensure removal of potentially contaminating residues. A firm may elect to sample its glassware for residual contamination to exclude or explore the possibility of interference in the case of particularly sensitive analyses or difficult-to-clean compounds.
The possibility of carryover contamination affecting a method’s performance or integrity of the results is generally considered of low risk to the product and consumers, with the exception of potent compounds. Contaminated laboratory equipment, however, should not be a frequent excuse for rejecting or discarding aberrant results. Glassware that is not properly cleaned can make it difficult to determine if the source of aberrant analytical results is related to the unclean glassware or residues from manufacturing equipment. We expect firms to maintain laboratory equipment in a clean and sanitary manner to provide confidence in the analytical results.
Reference:
21 CFR 211.67: Equipment cleaning and maintenance
Date: 6/8/2015 |
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