What is a Product Quality Review?

A pharmaceutical Product Quality Review (PQR) involves the regular or ongoing assessments of all authorised human and veterinary medicinal products manufactured by or for a Marketing Authorisation Holder, including those designated for export. The primary goal of a PQR is to confirm the consistency of the existing process and the correctness of specifications for both starting materials and the finished product.

Alongside the specifications, a PQR should assess and validate the consistency of product quality, identify any detected trends, and implement any required enhancements in the manufacturing process. Analysis of the review results should also determine if any corrective and preventive actions (CAPAs) or revalidation are necessary under the Pharmaceutical Quality System.

Management procedures must be established for the continuing oversight and review of any actions, with the effectiveness of these procedures verified through self-inspection. In cases where the marketing authorisation holder is not the manufacturer, a Quality/Technical Agreement should be in place, outlining the responsibilities of each party in conducting the product quality review.

PQRs plays a crucial role in a pharmaceutical company’s quality management system, enabling the continuous monitoring of product quality, ensuring compliance with regulatory standards, and serving as a mechanism for ongoing improvement in manufacturing processes to ensure effective patient safety and other efficiencies.

Click here for European Commission GMP guidelines volume 4 including Product Quality Review.

Product Quality Review checklist.

Typically, PQRs are conducted and documented on an annual basis, taking into consideration previous assessments. They should include at a minimum:

A review of starting materials, with a focus on packaging materials used in the product, especially those sourced from new origins. This includes a specific examination of the supply chain traceability of active substances.
An evaluation of critical in-process controls and the outcomes of finished product assessments.
A comprehensive analysis of batches that did not meet established specification(s) and the corresponding investigative processes.
An assessment of significant deviations or non-conformances, along with their related investigations and the efficacy of ensuing corrective and preventive actions.
A thorough review of all modifications made to processes or analytical methods.

An examination of Marketing Authorisation variations submitted, granted, or refused, encompassing those pertaining to third-country (export only) dossiers.
An overview of the results derived from the stability monitoring program, including identification of any adverse trends.
An analysis of all quality-related returns, complaints, recalls, and the investigations conducted at the time.
A review of the adequacy of prior corrective actions related to product processes or equipment.
For new marketing authorisations and variations to existing authorisations, a comprehensive assessment of post-marketing commitments.
An evaluation of the qualification status of related equipment and utilities, such as HVAC, water, compressed gases, etc.
A review of contractual agreements to confirm they are current and relevant.

Why choose Aegisana’s Product Quality Review services?

In-depth expert support.

Our GMP Compliance team can provide a comprehensive suite of PQR services and solutions for your manufacturing and packaging requirements. This includes everything in the above PQR checklist plus:

Processed batch review.
Analytical data review.
Stability data review.

Supported by a robust Quality Management System (QMS), we can seamlessly and efficiently adapt to the compliance needs of your manufacturing site.

Confidence through commitment.

Our goal is to provide you with peace of mind and confidence by providing a thorough, detailed Product Quality Review for complete compliance, safety, and manufacturing improvement and efficiency.

Through effective communication, reliability, and trust, we aspire to establish a successful and robust strategic compliance and auditing partnership throughout the production of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.