Annual Product Quality Review (APQR)

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“APQR is a Annual Product Quality Review somewhere known as APR (Annual Product Review)”

APQR contains a documented evidence oriented review of all activities related to a product manufactured in a organization, it covers all parameters which affects a product quality from Manufacturing stage to market performance. It is a support to quality system to know the smoothness of product quality system, technically it can be defined as:

“A review, conducted annually to give an organized and comprehensive summary of all production activities, analytical and physical, Stability, Deviations, Change controls, Out of specifications recalls and market complaints, which assess the quality standards of each drug product.”

The annual product review report shall be prepared annually for the period it can be a calendar (Jan. to Dec.) year or financial year (march to April) and called cut off date for finalization of APQR.

Headings of APQR include the following (not limited to below, can be more elaborate)

  • Review of total number of batches manufactured in the cut off period.
  • Raw material, Packing material and finished product analytical and physical reports.
  • Review of sources of starting materials (should be from approved vendors) and packing materials used for the product.
  • Number of batches rejected and their investigation.
  • Review of changes to approved manufacturing, packing and testing methodologies etc.
  • Review of the batch records and quality control reports.
  • Any corrective action or re-validation 
  • Quality trends which includes in-process and quality control data, alert limits (trend limits) should be established for all critical parameters. The established limits should be checked and reviewed.
  • A brief summery of all batches kept on stability for the product.
  • Details of deviation reports/change controls, if any, should be given along with document reference number.
  • Details of out of specification results.
  • Product complaints received, returned goods, field alert issue and recall if any, along with their investigation reports and corrective action. Document reference to be given.
  • Review of any regulatory changes.
  • Details of Licenses status and cGMP certification.
  • Completed APR summary and recommendations’s review and approval by HODs Quality & relevant.

Based on the above data, prepare the annual product review report.

Conclusion:

Conclusion of any APQR is very Important, because it states the actual health of a product’s Quality. After a fine review we can state  an APR’s conclusion into followings:

  • Process in control: This indicates no abnormalities within sets of data and confirms that the process continues to function as validation
  • Action recommended: This indicates that some recommended action should be considered, but the process is essentially functioning as designed and validated i.e. the process continues to operate in a state of control.
  • Corrective action required: This indicates need for immediate actions or corrections.

The data should be collated and report should be handwritten or printed.

The Annual product report should be compiled by Production, reviewed by Quality Assurance and approved by Quality Head.

Note:   If packing of the batch is not done / completed in the year of manufacturing, the details of packing and quality control parameters of the same batch should be included in the next year’s annual product review

References: 21 CFR part 211.180 (e)

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