Product Quality Reviews (PQRs) serve as a cornerstone in GMP, comprehensively evaluating production and quality control processes. This systematic review confirms product quality and consistency and identifies areas for improvement, ensuring that every batch produced meets the highest standards.
A Product Quality Review (PQR) is a comprehensive evaluation of the production and control of a pharmaceutical product. It is designed to verify the consistency of the process, identify any trends, and ensure that the product remains in compliance with regulatory standards.
PQRs are essential for maintaining the integrity and safety of pharmaceutical products, providing a detailed review of every aspect of production from raw materials to finished products.
The primary purpose of a PQR is to systematically evaluate the quality of a pharmaceutical product over a specified period. This ongoing assessment ensures that the manufacturing processes consistently produce products that meet predefined quality standards and regulatory requirements. By reviewing data from various batches, PQR aims to achieve several critical objectives:
The frequency of conducting Product Quality Reviews (PQRs) is typically on an annual basis. This annual frequency is a regulatory requirement set by major health authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Conducting PQRs annually ensures continuous monitoring and improvement of product quality, which is essential for.
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