Pharmaceutical Quality System

 A pharmaceutical quality system refers to the formalized and documented processes, procedures, and policies that ensure that pharmaceutical products are of high quality, safe, and effective. It includes a framework of interrelated processes, which encompass all activities from research and development through manufacturing, packaging, labeling, distribution, and post-marketing surveillance. The pharmaceutical quality system is designed to ensure that products are consistently manufactured according to established standards, with a focus on continuous improvement, risk management, and patient safety.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed a guideline on Pharmaceutical Quality System (ICH Q10) that provides a framework for an effective quality management system for the pharmaceutical industry. The guideline emphasizes the importance of a quality culture that is based on a proactive approach to quality, risk management, and process understanding. It also emphasizes the importance of management responsibility, continual improvement, and a lifecycle approach to product development and manufacturing.

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