PQR评估的周期性

beiwei5du

提问：FDA的PQR必须至少是一年进行一次回顾吗（不管一年中批次数有多少）？？？

FDA and EU require an annual frequency for the PAR/PQR, which is stated inall three GMP regulations and the guidance document. FDA does not allow the extension of the review frequency beyondan annual basis, regardless of the number of batches produced in the preceding12-month period. FDA expressed the concernthat "Potentialproblems with product quality standards could go undetected and thereby delayrecognition of a need to revise specifications or manufacturing or controlprocedures"(8).

选自http://www.pharmtech.com/product ... 1&sk=&date=

§211.180   General requirements.

(e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for:

(1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch.

(2) A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under §211.192 for each drug product.

(f) Procedures shall be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations conducted under §§211.198, 211.204, or 211.208 of these regulations, any recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration.

[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]

beiwei5du

而针对于欧盟或者其他国家，则一年中某产品生产批次较少的情况下，也是允许在风险评估的前提下进行多年一次的PQR？？？

20. Do Product Quality Reviews (PQRs) have to be conducted yearly?
Yes. However, if very few batches of one product are manufactured in one year, it may also be acceptable to conduct a two yearly PQR providing a rationale is documented and scientifically justified. The justification for a reduction in the frequency of reviews should consider whether the medicines are registered, listed or complementary, the number and size of batches manufactured, whether grouping is utilised (see question 19) and the method of manufacture, together with an assessment of the risk associated with the product. The approach taken by the manufacturer will be assessed on a case-by-case basis.


选自澳大利亚TGA官网

beiwei5du

13. One comment suggested allowing a biennial review to permit trend analysis when three or fewer product batches are produced each year. FDA disagrees with this comment. The agency believes that a 2-year interval between formal review of batches is inadequate. Potential problems with product quality standards could go undetected and thereby delay recognition of a need to revise specifications or manufacturing or control procedures. If a serious error is not detected for a long period, the resulting product could pose a threat to public health and safety. Moreover, a trend analysis may be performed in situations where only a few batches are produced annually by using batches produced in preceding years. （和过去的批次数据进行趋势分析）

静水蓝心

谢谢分享

xqliu

学习一下啦，谢谢提供分享。

86419405

学习了！看起来有点吃力

beiwei5du

正是由于上述原因，专业的讲法的话，在美国一般使用PAR（product annual review）,而在欧盟则一般使用PQR（product quality review）!