Follow
1.0 The majority of GMP regulatory bodies has made it a mandatory for the companies to have a written procedure for the Annual Product Review process and recommends the review of all the batches that are manufactured in the preceding year from January 1st to December 31st. And the batches include both approved as well as rejected batches.
2.0 The configuration of an annual product review report can vary based on different products and a company’s specific documentation requirements.
3.0 However, a company should follow a standard template to ensure that all required aspects are evaluated.
4.0 As an APR is an evolving document. It should be of few sections with minimal requirements to an elaborate document with addenda containing information or data relevant to the product.
5.0 An Annual product review report should contain the following chapters
5.1 Finished product and Half finished product testing results.
5.2 Critical in-process controls.
5.3 Quality and yield review of failed batches (OOS) & and CAPA has taken
5.4 Deviations and CAPA has taken against each deviation, effectiveness of CAPA on later manufactured batches.
5.5 Review of reprocessed/ reworked batches and the reason for reprocess/ rework of the batches.
5.6 Changes proposed, approved and implemented that are directly or indirectly related to the product, in-case if a change control is raised related to a multi-product facility should be mentioned in the annual product review report of all the products that are manufactured in the facility.
5.7 Validations (Process or Analytical method) if get triggered by the changes made.
5.8 Repacking made
5.9 Regulatory filings made, or updates made in the existing DMF that owed to the changes made
5.10 Stability studies and any OOT result found at any station, its investigation outcome should also be addressed. Details of add-on batches for stability studies.
5.11 Return goods, complaints, recalls, noted for the product.
5.12 Critical equipment qualifications.
5.13 Quality agreements made for the product.
5.14 Effectiveness of CAPA mentioned in the previous year APR.
5.15 Unresolved or open issues of previous year APR.
5.16 Review of starting materials including packaging materials used for the product.
5.17 Retain sample review
5.18 Each numbered sub-section typically should be followed by a comment or observation and finally should have a cumulative summary of the report.
5.19 And the document should finally be reviewed by all the concerned departments, approved by the management and authorized by the quality head.
