Product Quality Review
Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify
product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews.
Product Quality Review -Questions and answers
Q1: What is the purpose of conducting product quality reviews of medicinal products?
A1: The purpose of conducting regular quality reviews is to ensure the consistency of the manufacturing process, the appropriateness of specifications for starting materials and finished products, and to identify any trends or areas for improvement in the product and its manufacturing process.
Q2: How often should be conducted product quality reviews?
A2: product quality reviews should normally be conducted and documented annually, taking into account previous reviews.
Q3: What elements should be included in the product quality reviews?
A3: The quality reviews should include the following elements:
A review of starting materials, especially those from new sources, including packaging materials, with a focus on supply chain traceability of active substances.
A review of critical in-process controls and finished product results.
A review of batches that failed to meet specifications and their investigation.
A review of significant deviations or non-conformances, their investigations, and the effectiveness of corrective and preventive actions.
A review of changes made to processes or analytical methods.
A review of Marketing Authorization variations submitted, granted, or refused, including for export-only products.
A review of stability monitoring program results and any adverse trends.
A review of quality-related returns, complaints, and recalls, along with investigations performed.
A review of the adequacy of previous corrective actions related to product, process, or equipment issues.
For new marketing authorizations or variations, a review of post-marketing commitments.
The qualification status of relevant equipment and utilities, such as HVAC, water, compressed gases, etc.
A review of contractual arrangements to ensure they are up-to-date.
Q4: Why is the review of starting materials and supply chain traceability important in product quality reviews?
A4: The review of starting materials, including their sources and supply chain traceability, is crucial to ensure the consistency and quality of the finished product. It helps identify any potential risks associated with new sources and ensures that the supply chain remains reliable and compliant.
Q5: Why is it necessary to review batches that failed to meet established specifications during product quality reviews?
A5: Reviewing batches that failed specifications is essential to understand the root causes of the failures, identify potential trends, and implement corrective actions to prevent similar failures in the future.
Q6: How does the review of stability monitoring program results contribute to product quality?
A6: Reviewing stability monitoring program results helps identify any adverse trends in the product’s stability over time. This information is critical for ensuring that the product retains its intended quality and efficacy throughout its shelf life.
Q7: What is the significance of reviewing quality-related returns, complaints, and recalls in product quality review?
A7: Reviewing quality-related returns, complaints, and recalls provides insights into any issues customers or regulators have encountered with the product. This helps identify areas for improvement, ensure patient safety, and maintain regulatory compliance.
Q8: Why is reviewing contractual arrangements important in the product quality reviews?
A8: Reviewing contractual arrangements ensures that any agreements related to the product, such as those with suppliers or partners, are up-to-date and aligned with current quality and regulatory standards.
Q9: How can product quality reviews contribute to continuous improvement in the manufacturing process?
A9: By analyzing trends, deviations, corrective actions, and other elements, these quality reviews help identify opportunities for process improvement, leading to enhanced product quality and operational efficiency.
Q10: How do product quality reviews help in maintaining regulatory compliance?
A10: Regular quality reviews ensure that the manufacturing process and the product remain in compliance with regulatory requirements. They provide evidence of ongoing quality control and efforts to address any deviations or non-conformances.