According to the Code of Federal Regulations (21 CFR 211.22(a) Responsibilities of quality control unit), the quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.
A company recently received the following observation:
…. The quality control unit lacks authority to review production records to assure that no errors have occurred.
Specifically, a review of the batch records from the contract manufacturer for the … drug products was not performed by your firm before you released them to the market.
The batch records were stored at the contract manufacturer located …. and had not been reviewed by your firm until requested during the current inspection. As the Quality Agreement between your firm and contract manufacturer, only Certificate of Compliance is provided by the contract manufacturer upon release for shipment to your firm. Additionally, executed batch records are only provided to your firm after a request.
For more information on what should be included in a batch records, refer to the following: 21 CFR 211.186 Master production and control records, 21 CFR 211.188 Batch production and control records, and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Issued September 2016.
For more information on how to establish and maintain quality agreement with your contract manufacturer, refer to the following FDA guidance document: Contract Manufacturing Arrangements for Drugs: Quality Agreements Issued November 2016.
To view more observations pertaining to quality agreements, refer to the following GMP Trends® Issues: 1054, 1049 and 1057. To view more observations pertaining to batch record deficiencies, refer to the following GMP Trends® issues: 1059, 1057, 1055.
For more observations pertaining to quality systems, see our new Issue 1064 available today. It also has observations pertaining to manufacturing controls, medical devices and packaging and labeling.
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