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关于raw material是否包含在PQR中的进行回顾的说明 As an example, the authors have seen FDA 483s criticizing the failure totrend raw-material test results as part of the PAR for a product. To determinewhether this is a valid FDA 483 observation or whether raw-material trendingshould be included, the following should be considered. If the trending of araw material (e.g., an active ingredient) identifies an adverse trend (e.g.,more than 25% of all lots received in the past 12 months were rejected and sentback to the supplier), would this adverse trend cause the company thatperformed the PAR to change its manufacturing process for the drug product, themanufacturing controls for the drug product, or the final releasespecifications for the drug product? When the answers are "no" to allthree parts of this question, raw-material trending should not be included aspart of the PAR because any result from this trending would not be relevant tothe objectives of the PAR and would not generate any follow-up action forimplementing changes. To avoid confusion, this example is not to suggest thatraw-material trending is not needed, but that it should be performed as part ofanother program (e.g., vendor qualification program) instead of the PAR program. It should be noted that the EU PQR requiresthe evaluation of the appropriateness of the raw-material specifications.
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