PROCEDURE FOR ANNUAL PRODUCT QUALITY REVIEW (APQR)

1.0 Objective:
 To lay down the procedure for carrying out the Annual Product Quality Review (APQR)
 To describe the procedure for Product Quality Review (APQR) to verify the consistency of
the existing process, the appropriateness of current specification for both staring materials
and finished product and to identify the product and process improvements.

2.0 Scope:
 This SOP is applicable for the Annual Product Quality data collection and Review (APQR).

3.0 Responsibility:

Quality Assurance Officer

- Preparation of report for annual product quality review (APQR)

- Collection and compiling the data for continuous monitoring
- To prepare the interim Product Quality Review (APQR) Report

General Manager

- Approval of the Product Quality Review (APQR) report

- Suggest CAPA/recommendation in Product Quality Review (PQR)
- Ensure continuous monitoring data

Supervisor

- Organize production-related data for compilation

- Suggest CAPA/recommendation in Product
- Ensure continuous monitoring of data

Quality Control Officer

- To prepare QC related data for compilation.

- To review Product Quality Review (APQR) for QC related data and information.
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4.0 Procedure for preparation and Review of Product Quality Report
1. APQR shall be carried out for each product manufactured in the year.
2. Products manufactured in the previous twelve (12) months shall be taken for APQR on a
staggered basis covering all the batches manufactured.
3. Priority on scheduling can be given on a risk-based approach (i.e. Market complaint, Product
recall, Stability or any other issue) if required.
4. APQR shall be completed within 90 days, for; for example APQR for products manufactured
during the period of January-December 2022 shall be completed by March 2023.
5. The APQR calendar shall be prepared by the quality assurance officer and approved by the
General Manager before execution.
 6. APQR shall be prepared product-wise and shall include all batch size different code in single
APQR.
7. APQR shall be prepared as per defined schedule at least once a year

In case no batch is manufactured during the review period then APQR shall be prepared with a
review of all available documentary data like:
- Complaint review
- Stability Data
- Observation of control /retain sample
- Variation approval
- Product recall, etc.

Numbering System of Annual Product Quality review report (APQR):

- APQR number shall be numbered as APQR/ZZ/XXX where:

 APQR denotes “Annual Product Quality Review”
 ‘ZZ’ are numerica denotes the calendar year for example 22 for 2022and so on.
 ‘XXX’ are numerical denotes the serial number starts from 001

The review shall include the following aspects:

Production information shall contain the details

- Product name
- Batch Number
- Specification