How to conduct product quality review in pharmaceutical

f. Component quality

A review of all starting materials and primary packaging in contact with the product should be completed. 

This will include supplier performance assessment and identifying any critical deviations associated with active or excipient ingredients, primary packaging, and closure material.

Suppliers of all active materials should be listed, and they should be considered as a suitable supplier.

I want to inform you that particular attention must be given to new suppliers.

All deviations associated with raw materials that may have product impact must be assessed concerning whether the material is an active pharmaceutical ingredient (API), excipient, or primary packaging.

The impact of any raw material changes or deviations on the finished product must be assessed.

g. Market activities

A review of market activity should include all quality-related product returns, complaints, and recalls. 

The product quality review will include details on investigations that occurred during identification.

You must have a summary of all complaints or adverse events during the review period.  Details of how each issue was resolved should be provided.

Details of any recall activity must include the following:

– The reason for the recall

– Any investigations conducted

– Regulatory response

– Corrective actions

– Current status

Just to let you know, details of returned goods, quality issues, and final disposition of goods are required.

Any corrective actions that have been taken are to be assessed for efficacy.

h. Regulatory assessment

A summary of changes in specification registered with local or international government regulators must be included.

Any post-marketing commitments should be reviewed and their status assessed.

Any deviation notifications reported to regulatory agencies must be documented, and follow-up actions and current status must be identified.

Regulatory agency inspection commitments that relate specifically to the product must be outlined.

Any regulatory submission filed or closed during the review period is to be reported.

i. Validated / qualified status

The review should include details of all product-related validation activity initiated or completed during the product quality review period.

All validation/qualification studies commenced or completed during the review period must be assessed.  These may include:

– Process validation

– Packaging validation

– Cleaning validation

– Analytical method validation

– Equipment validation

Any identified significant issues and deviations must be discussed and resolved, and the effectiveness of the validation must be determined.

j. GMP agreements

All GMP agreements relevant to the product or production process must be reviewed to ensure that the contract between manufacturer and supplier covers all aspects of manufacture.

All suppliers needing an agreement should be identified, and a reference should be provided to existing agreements.

Currency and relevance should be assessed concerning any revisions or changes.

GMP agreements should cover all technical requirements for periodic production and laboratory equipment maintenance.

Prepare a report on product quality review

The annual product quality review summary report should provide a comprehensive overview of the data contained within the different elements of the product review.

The summary needs to provide:

– An analysis of the performance of the products

– A review of all the elements reported

– A summary of any trends or concerns

– Identification of any previous issues or corrective actions

– A conclusion as to the suitability of the product for ongoing production

– A rating of product performance based on the report

The summary should stand alone as a report and provide sufficient detail for senior management to assess product performance.

Tracking the recommendations

All annual product quality review recommendations must be addressed and tracked through the Corrective and Preventative Action (CAPA) program.

The CAPA should cross-reference the product quality review. Subsequently, the effectiveness of the corrective actions should be documented.

Approval and review process

The completed product review must be approved by the:

– Production Manager

– Quality Manager

Following approval, the controlled copies are to be circulated to the following:

– Production Manager Biologicals or Pharmaceutical (as relevant)

– Quality Control Manager

– Quality Assurance Manager

– Production Manager

The master document is to be maintained by the QA group.

Escalation of product quality review report

Any significant concerns about product quality or trends must be escalated to the head of the GMP site.

A list of substantial concerns may include the following:

– Consistently Out of Specification results

– Unexplained trends

– Regulatory commitments that have not been met

– Failed validations

– Regulatory non-compliance

– Anything that may result in product recall

Conclusion

The main objective of an annual product quality review is to see if your product consistently maintains its expected quality and to identify any needed improvements to ensure consistency with your manufacturing process.

You should have standard operating procedures and templates describing how to review individual aspects of product quality and how to trend your product quality.

The review analysis should cover areas such as production process, product specifications, major deviations, out-of-specification results, validation status, test methods and test results, stability studies, change of raw materials and packaging components, complaints, recalls, and other market and regulatory actions.

You must prepare a comprehensive summary report of your findings and observations from the review.

Use statistical analysis to prove if the product is maintaining its expected quality.

If you find any adverse trend during the review process, please take corrective and preventive actions.

Prepare your recommendations to improve the product quality in your summary report.  

The conclusions drawn from the annual product quality review must be reviewed through the site quality council.