Annual Product Quality Review Procedure


Annual Product Quality Review Procedure


The purpose of this Sop is to provide guidance for performing and documenting annual product reviews. and it’s also a GMP requirement to provide reliable procedures for a drug manufacturer to review the quality standards for each drug product.

Annual Product Quality Review:

Annual product review is an evaluation conducted annually to assess the quality standard of each drug product with the view to verify the consistency of existing process and to check the appropriateness of current specifications and to highlight any trends in order to determine the need to change any drug product  specifications or the manufacturing processes or control Procedures

It is an effective quality improvement tool to enhance the consistency of the process and the overall quality of the product. It will capture a broader view of product data, capturing trends, and will help to determine the need for any revalidation or any changes.

Importance of Annual Product Quality Review:               

  • It verifies the consistency of the existing manufacturing processes.
  • It determines the quality and process defects of the products.
  •  It determines the defects and possible improvements of the methods and process.
  • The trend of yield, analytical results, and manufacturing parameters of the product are also highlighted.
  • It reviews the quality of the raw material and packaging material which is used for the product.
  • To determine the consistency of the quality of the product the in-process parameters and the finished product results are reviewed.
  • The quantity of the final product is reviewed by trending the yield of every batch.
  • Out of specification parameter helps to determine the product defects.
  • If any of the batches is failed, then it is also included in the Annual Product Quality Review to determine the batch rejection of the product.
  •  For the determination of the stability of the product, a stability study and its trend are performed.
  • It also helps to determine if there is any re-validation of the process and the effect of any improvement made previously.
  • The determination of the Corrective and preventive actions and their impact on product quality are also reviewed

Basic Contents of Annual Product Quality Review:

Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:

  • A review of starting materials including packaging materials used in the product, especially those from new sources.
  • A review of critical in-process controls and finished product results.
  • A review of all batches that failed to meet established specification(s) and their investigation.
  • A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken.
  • A review of all changes carried out to the processes or analytical methods.
  • A review of Marketing Authorisation variations submitted/granted/ refused, including those for third country (export only) dossiers.
  • A review of the results of the stability monitoring program and any adverse trends.
  • A review of all quality-related returns, complaints, and recalls and the investigations performed at the time.
  • A review of the adequacy of any other previous product process or equipment corrective actions.
  • The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc
  • Annual product review shall be carried out for each product manufactured in the previous calendar year.
  • The annual Product Review report should be completed by the month of January.
  • Annual product review records shall be maintained in the QC department.


Thus Annual product Quality Review is an evaluation conducted annually to assess the quality standard of each drug product with the view to verify the consistency of the existing process and to check the appropriateness of current specifications to manufacture the pharmaceutical product. Thus it is necessary to study the regulatory requirements for the preparation of the Annual

Product Quality Review to manufacturing the pharmaceutical product according to the GMP

requirements and which is safe and effective to the public. Hence to study the regulatory requirements is essential.


1.0 Annual Product Review process, recommends a review of all the batches that are manufactured in the previous 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 agenda containing information or data relevant to the product.

5.0  An Annual product review report should contain the following information.

5.1  Finished product testing results.

5.2  Critical in-process controls.

5.3 Quality and yield review of all batches out of specification (OOS) & and  CAPA taken

5.4  Deviations and Corrective and preventive action (CAPA) have taken against each deviation, effectiveness of CAPA on later manufactured batches.

5.5  Review of reprocessed/ reworked batches and reason for reprocessing/ rework of the batches.

5.6 Changes proposed, affirmed, and executed that are straightforwardly or in a roundabout way identified with the item, on the off chance that if a change control is raised identified with a multi-item office ought to be referenced in the yearly item survey report of the relative multitude of items that are produced in the office.

5.7  Validations (Process or Analytical method) if get triggered by the changes made.

5.8  Repacking made

5.9  Regulatory documentation made, or updates  made in the existing DMF that owed to the changes made

5.10  Stability studies of all batches.

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-segment normally ought to be trailed by a remark or perception lastly ought to have an aggregate rundown of the report.

5.19  And the document should finally be reviewed by all the concerned departments, approved by the Q. A  Officer & QC  Head.

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