NS05 Quality Control and Documentation

The course on Pharmaceutical Quality Control and Documentation covers a range of topics related to ensuring the quality and compliance of pharmaceutical products. It provides a comprehensive overview of the principles, techniques, and regulatory requirements involved in quality control processes within the pharmaceutical industry. It explores the various quality control tests and methodologies used to assess the identity, purity, potency, and quality attributes of pharmaceutical products.

The course also delves into the documentation practices essential for maintaining compliance with regulatory standards. Special attention is given to Good Documentation Practices (GDP) and the importance of accurate and reliable record-keeping throughout the product lifecycle.

Participants will also gain an understanding of the regulatory landscape governing pharmaceutical quality control. Additionally, the course addresses quality control deviations and investigations, including root cause analysis and corrective and preventive actions (CAPA). It provides insights into the implementation of quality risk management strategies and the role of quality control in ensuring continuous improvement and minimizing product defects or recalls.

Throughout the course, practical examples, case studies, and interactive exercises may be utilized to enhance learning and demonstrate the application of quality control principles in real-world scenarios.