This document developed by World Health Organization presents a comprehensive guideline to ensure the quality of pharmaceutical products during their manufacturing process. The document traces its origins to a draft text on good manufacturing practices (GMP) prepared in 1967 and has undergone multiple revisions to incorporate the evolving standards and practices in the pharmaceutical industry.
The guideline emphasizes the importance of a robust Pharmaceutical Quality System (PQS) that integrates Good Manufacturing Practices (GMP) and Quality Risk Management (QRM). Senior management is highlighted as having the ultimate responsibility for ensuring an effective PQS, emphasizing their leadership role in ensuring product quality.
The document covers various aspects of quality management in the medicines industry, emphasizing that it encompasses all factors that influence the quality of a product. It underscores the need for a system that consistently delivers products with the right quality attributes. The PQS should be adequately resourced, including competent personnel, suitable premises, and appropriate equipment.
The guideline also touches upon the importance of product and process knowledge management throughout all life-cycle stages. It advocates for the integration of product design and development into the quality management process, ensuring that pharmaceutical products are of the required quality for their intended use.
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