Procedure for Preparation of APR (Annual Product Review) : Pharmaceutical Guidelines

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Procedure for Preparation of APR (Annual Product Review)

Learn how to prepare a Annual Product Quality Review Report (APQR) for Pharmaceutical products.
Each APR, compiled by Manager - QA should cover the preceding year's production. Data/information will be provided by the appropriate owners to Manager - QA, who is responsible for preparation of Annual Product Quality Report. Any outstanding actions from the previous review shall be noted. To provide a comprehensive review, the following content shall be included:
  • Introduction
  • Review of Preceding APR
  • Master Manufacturing Documents
  • Control of deviations
  • Review of Analytical and Process Data
  • Details of OOS results
  • Details of Product failure
  • Complaints/Returns/Recalls
  • Stability Data Review

Summary:

Document whether the review indicates problems / potential problems with the manufacturing process, analytical specifications or any other associated area. Any quality improvement or initiatives may also be recorded here.

Annual Product Quality Review report shall be done for the API manufactured in the financial year from 1st Apr to 31st Mar.

APQR of financial year shall be completed within three months from the date of completion of financial year.
Distribution of APR:

Contents all the APQR will be discussed in the meeting with Vice president – technical & Vice president - Operation and copies of authorized APQR will be distributed to:
  • Head - CQA
  • Head - P&D
  • Manager - QA (Master copy)
Also see: Importance of APR in Quality Improvements





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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