Annual Product Review - GMP SOP
An annual product review (APR) should be conducted for every commercial product. The purpose of this review is to verify the consistency of the manufacturing process, assess trends, determine the needs for changes in specifications, production, manufacturing and/or control procedures and evaluate the needs for revalidation.
This APR is reported and approved in a product-specific annual product review report. Our 8-page APR SOP summarises FDA CFR expectations and PIC guidance. It also includes a 6-page, ready-to-use APR template. The SOP and template only need a small amount of site-specific modification before they can be adopted for your operations.
Table of Content
1. Regulatory Reference
4. Responsibilities and Accountabilities
4.1 Quality Assurance
4.3 Quality Control
4.4 Regularly Affairs and Clinical Safety
5.1 APR framework
5.2 APR tools
5.2.1 Trend analysis
5.2.1 Mean charts
5.2.2 Range Evaluation
5.3 APR report checklist
5.3.1 Recommendations from prior APR report
5.3.2 Batches manufactured
5.3.3 Batches rejected
5.3.4 Batches reworked/reprocessed
5.3.5 Deviations, Out of Specification Results (OOS)
5.3.6 Environmental monitoring data
5.3.7 Product Specification/Method Changes
5.3.8 Retain samples (US)
5.3.9 Changes effected (Change Control)
5.3.10 Analytical data
5.3.11 Validation review
5.3.13 Customer Complaints and Returns
5.3.14 Adverse Drug events (US marketed products only)
5.3.15 Inspections from any official inspectorate
5.3.16 New recommendations
Annual Product Review Report Template 6 pages
|SKU||Annual Product Review - GMP SOP|
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