Procedure for Annual Product Quality Review

1.0 Introduction

Annual product quality review is prepared in compliance with cGMP requirements. They are crucial part of good manufacturing practices and also quality management of a pharmaceutical product. The quality review process is done annually to evaluate the quality standards of the ongoing process and also the specifications or control procedures. It is given for every product as a written procedure to reduce the risk in the production.

1.1 Product quality review

Quality review is done on regular periodic time for licensed medicinal products along with exported products. This serves as an effective tool to improve the process consistency and overall product quality. It provides a broader view on the products data, trends and any other changes which justify the need to revalidation.

1.2 Significance of Annual product quality review

It checks the appropriateness of existing manufacturing process

It determines the defects in process and quality of products

It determines the defects in methods

It evaluates analytical results, yield trends and products manufacturing parameters

It evaluates the quality raw material and also the packaging materials

It indicates the material quality

It reviews the appropriateness of product quality, in process parameters and also the results of the finished products

Final product quantity is reviewed by yields trends for every batch

Product defects are determined by the out of specification parameters

Failure of a batch is also included in the annual product quality review to determine the reason for its failure

Stability study and trends are done to determine the stability of the product

CAPA are also determined to know their effect on product quality

1.3 Contents of Annual Product quality review

The reviews conducted annually should include the following:

Review on starting and packaging materials particularly which are derived from new sources

Review on in process controls & results of finished products

Review of batches which haven’t met the specifications

Review of deviations from CAPA

Review of changes in analytical methods & processes

Review of marketing authorization variations which are granted or submitted or reviewed

Review of stability monitoring programmes and adverse trends

Review of returns, complaints, recalls concerned to quality and investigations performed at tha period

Review of corrective actions for equipments and product process

Review of post marketing commitments for variations in marketing authorizations

Qualification status of equipment and utilities

1.4 Regulatory requirements

1.4.1 Starting materials

All starting materials and packaging materials are identified which are received and used for manufacturing

It should include name of manufacturers and suppliers of the materials

It should include certificate of analysis for the supplier or certificate of compliance

Analytical tests like LOD, LOQ, range, linearity, ruggedness and robustness should be tested and included

Any changes with regards to process or specifications should be included

Any deviations from specifications should be included

1.4.2 Packaging materials

Written procedures for handling, identifying, storing, sampling, testing and labelling should be included

All the packaging & labelling materials should be sampled & examined before labeling & packaging of the product

The materials which are in compliance with the specifications should be approved and then released for use.

If they don’t meet the specifications then they are rejected and should be mentioned in annual product review

Record should be available for shipment of every different labeling & packing material with receipt, testing and examination. It should be reviewed as to it is accepted or rejected

Labeling materials and labels for every drug product its dosage form, strength and the quantity of contents should be stored with distinct identification

Electromechanical equipment should be examined thoroughly for accurate labeling during and after finished operations are done

If any automated technique is used to provide accurate labeling then the name of the technique should be included

1.4.3 In-process controls & QC testing

Written procedures for production & process controls should be designed ensuring the drug products have identity, quality, strength and purity for which they are represented

Any changes in the specifications or procedures should be drafted, reviewed & approved by organizational units and QC unit

Results from QC tests and in process trends tests for both manufacturing & packaging process should also be included

Any physical variations like friability, weight, hardness, disintegration time, hardness, dissolution time, content uniformity and fill volume or overage should be included

Rejected products like particulates and breakages should be included

Yield obtained in manufacturing process should be included

1.4.4 Manufactured batches

Any deviations and non-conformances in the products should be mentioned

Deviations and CAPA should be mentioned

Causes for failures should also be mentioned

1.4.5 Changes in process or testing

Any changes in the process of manufacturing and changes occurred should be clearly mentioned

Changes in analytical methods, packaging & labeling should be mentioned

Initially the batches should be identified and change made should be justified and the change should be evaluated

1.4.6 Marketing authorizations

Variations in the marketing authorizations and also in the dossiers should be mentioned

The number of products granted or refused or submitted should be included

Number of products registered overseas or locally should be mentioned

Variations should be submitted and if not submitted they should be documented with conclusion

1.4.7 Stability Programmes

Review of the results of ongoing bulk product or long term product should be done

The results should be included

Product information like shelf life and manufacturing date should be included

1.4.8 Returned product

The batch number of the returned product should be mentioned

Cause for returning product should be mentioned

Investigation report number given to the returned product should be mentioned

1.4.9 Adverse events

Identification and noting the product batch number

Complaint should be noted along with the reason

Complaints should be reported along & manufacturing should be ceased

Investigation report number given to the returned product should be mentioned

Present status of the product should be notified

1.4.10 Recalls

Number of batches or products recalled should be noted

Reason for recalling should be included

Investigation report number given to the returned product should be mentioned

Present status of the product should be notified

1.4.11 CAPA

Any corrective actions taken regarding process or equipment or product should be noted

Preventive measures taken should also be mentioned

1.4.12 Equipment qualification

The qualification status and the date for next qualification for equipment should be noted

Reference to the reports and changes made with proper review should be included

1.4.13 Contractual agreements

Review of contracts and the associated services with the product should be included

Name & address of contractor who accepts should be included

Details and availability of the written contract should be mentioned

The different services provided should be included

Annual product quality review, starting materials, packaging materials, in-process controls, qc testing, marketing authorizations, stability programmes, adverse events, capa, contractual agreements