Annual Product Quality Review (APQR/PQR) in Pharmaceuticals

What is APQR/PQR :

Annual product quality review is regular periodic quality reviews of all licensed commercial medicinal products which are conducted with the objective of verifying the consistency of the existing process, parameters, the rightness of current specification for both starting materials and finished products to highlight any trend, Deviation, change control, Market complaints and to identify the product and process improvements.

When APQR Shall be prepared:

Annual Product Quality Review (APQR) of the Drug Product shall be prepared for the Calendar Year (Period: January to December).

APQR shall be prepared for the batches which are manufactured for the Commercial purpose.

APQR  shall be prepared irrespective of number of batches manufactured during the year.

APQR Reference Guidelines :

EU-GMP Part – I, Chapter – I and 21 CFR – Parts 210 and 211 Subpart – J Records and Reports 211.180 (e), ICH Q7 and PIC/S.

Contents of APQR (But Not Limited to) :

  • Product Name, Generic Name, Strength, Market, Label Claim, Storage Condition, Shelf life, Primary and complete Packaging Configuration.
  • Product Batch No., Batch Size (Kg. and Units), Manufacturing Date and Expiry Date etc.
  • Data of Active Pharmaceutical Ingredients (API), Excipients, Primary Packaging Secondary packaging materials used.
  • Review of Equipment and Utility like Compressed air, Gases and HVAC system qualification etc.
  • Quality of water used in the process shall be reviewed and data shall be compiled for pH, conductivity, TOC and Microbial limit test.
  • Review of Batch Manufacturing Records and Batch Packing Records which include include following in process parameters (For Ex. LOD during drying, weight variation, Hardness, Friability, Disintegration test and weight gain in coating as minimum) critical process parameters (CPP) and critical quality attributes (CQA). Manufacturing and packing yield.
  • Review of Release Testing data which include in-process control checks and finished product analytical release testing data along with trend and graph.
  • Review of stability studies of commercial batches and review of stability trend and any Out of specification or Out of trend etc.
  • Review of Specification for Raw Material & Packaging Material and Drug Products.
  • Review of Product and Process related Validation activities.
  • Review of Change Controls & deviations & their status i.e open or close.
  • Status of Corrective and Preventive Action (CAPA) related to Process & drug Products.
  • Review of Out Of Specification (OOS) & Out Of Trend (OOT) Results if any.
  • Review of Product Complaints i.e number of complaints received and open & closed status etc.
  • Product Recall and Filed Alerts.
  • Review of Returned Finished Goods.
  • Review of Elemental impurities.
  • Review of Previous Annual Product Quality Review if any.
  • Conclusion shall contains the observations and the finding which are obtained during review of APQR.

The data of In process parameters obtained from manufacturing and packing, Analytical parameters of ( Blend, Filled capsule, Compressed tablets, coated tablets, Finished products, Raw materials and packing materials) and Stability data shall be calculated for Minimum, Maximum, Average and Cpk values .