SOP for Annual Product Quality Review Procedure

This document details the procedure for the Annual Product ReviewIt is the policy of XYZ Limited that written procedure shall be followed for the Quality review, with trend analysis, of the Starting material and drug product to ensure the acceptance of the product about the set specification by XYZ Limited throughout the year.

This procedure is applicable at the time of presenting the Annual data of the raw material and drug product in tabular form on an annual basis.


Persons along with their responsibilities are given below.

Executive- Corporate Quality Assurance:- To prepare SOP.

Director-Production/Manager–Corporate Quality Assurance:- To ensure implementation of SOP

Manager-Quality Control:- To check the data collected

Annual Product Quality Review Procedure

Annual product review (APR) shall be carried out to monitor and evaluate the quality of drug products manufactured by the company in one complete year. APR shall be used as a basis for quality review.

At the end of a calendar year, an annual al product review shall be carried out for each product manufactured by the company in that year. Along with the annual review, implementation of the preceding year's recommendations shall also be checked.

The following parameters shall be taken into account for an annual product review:

Product Name   

Composition & changes, if any

No. of batches manufactured

Trend analysis of critical quality parameters. (as per Annexure-III)

Quality complaints

Product recall

Returned and Salvaged goods

Non-conformance reports and in-process deviations.

Batch failures at various stages and their investigations.

Changes are made in the formulation process and packaging.

Change of Approved Vendor (as per Annexure-II)

Change in facility/ Equipment

% Yield of all batches with an average

Annual product review is done as per the Annexure attached and a summary report shall be made for each product on completion of the review. Trend Analysis for Finished Goods and In process parameters is as per Annexure.

Recommendation(s) shall be made in the report based on the review if any change is required. The report shall be sent to the Quality Assurance Manager of XYZ Limited for necessary action.


Trend analysis shall be done for Raw Materials and for all products manufactured in the last calendar year. Quality characteristics of drug products shall be compiled product-wise and batch-wise considering the following parameters.

Granule Stage: Sieve Analysis, Tapped Density.

Compression Stage: Av. Weight, Hardness, DT (if applicable), Friability, and Uniformity of weight.

Finished Product: Assay, Dissolution, Uniformity of content, Impurity / R.S., and Microbial Evaluation.

The yield of each stage shall be cumulated for review, to ensure that batch yield is within limits. If any deficiencies are observed, their comments/reasons for the same have to be reviewed. The action taken to avoid the recurrence should be highlighted in the Annual Product Quality Review.

The data of stability studies shall also be monitored during the Annual product review. Confirm that Stability data supports the shelf life, storage recommendations, and overages specified in Master Formula Instruction.

Review method validation protocol and reports if any new method of analysis is introduced. Quality characteristics of Raw materials shall be compiled, considering the following parameters: Assay, Impurity/ related substance (if applicable), LOD/Water, Sieve analysis (Particle size), and Bulk density.

SOP For Annual Product Review | Annual product quality review SOP

In the case of raw materials, the trend analysis card shall be limited to active raw materials only unless otherwise demanded by the tie-up company for excipients.

Data shall be recorded continuously as per the completion of batch analysis and summarized once a year usually at the end of a calendar year.

Any deviation shall be investigated by the Manager of Quality Assurance and documented in the trend analysis report. The results of the trend analysis shall be used for the Quality Review.

Corrective action (if any) shall be taken into account along with the Head of Production and Quality Assurance to improve the Quality of the product.

Quality Review

Quality Review shall be conducted for the evaluation of Quality systems, to determine the need for changes in the product specification, manufacturing, or control procedures, and also evaluate the quality systems adopted to match the GMP requirements.

The APR team, which consists of representatives of departments like QA, Production, Validation, and Engineering, shall carry out the quality review.

The APR team shall discuss and evaluate the following but not limited to

Trend analysis of each quality characteristic.

Reason for Re-validation / Market complaint / Product recall / Returned goods / salvaged / deviations / Failures / Changes or any other.

Corrective and preventive action based on the above points is followed as per SOP No XYZ/CQA/SOP-030 and the recommendation of the APR team shall be implemented.

All the records of the Quality Review shall be maintained by the Quality Assurance department, and a copy shall be sent to the Director’s office.

A copy of the non-compliance report (department-wise) shall be sent to Quality Assurance and   Director’s office.

Trend Analysis in Annual Product Review is finally complied by plotting a graph for all Critical parameters.

Download:-  All Annexure


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