QC - Batch Release

QC Review Prior to Batch Release

This department, which is part of the "quality control unit," gives the final approval in order to release a product to the market. When a batch production and packaging record is completed by the operational areas, it is sent here for careful review and - hopefully - approval. QC-Batch Release reviews all documents to be sure there are no loose ends (missing signatures, open deviations) and also examines testing data to confirm that the product meets specifications. If there is a significant problem with the product, GMPs require the QC-Batch Release group to reject the product and investigate why the problem occurred.

Example of a GMP expectation that applies to QC - Batch Release

As part of releasing a batch, the quality unit reviews all batch manufacturing and packaging records for correctness, completeness, and compliance to GMP.

Example of GMP requirements specific to this GMP expectation

  U.S.

• All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. [211.192]

  Canada

• The assessment for the release of finished products embraces all relevant factors, including the production conditions, the results of in-process testing, the fabrication and packaging documentation, compliance with the finished product specifications, an examination of the finished package, and if applicable, review of the transportation conditions. [C.02.014 # 2]

  European Union

• Finished product assessment should embrace all relevant factors, including the production conditions, the results of in-process testing, a review of manufacturing (including packaging) documentation, compliance with Finished Product Specification and examination of the final finished pack. [EU # 6.3]