Informa Healthcare - web catalogue

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification and documentation activities and procedural controls required for compliance. The author introduces appropriate supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system life cycle using a structured top-down approach. The material is presented through practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

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A Practical Guide to Quality Management in Clinical Trial Research

Examining how to maintain assured quality in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides solid foundations, tips, and techniques for establishing a quality system that will comply with the relevant regulations. This book offers useful information for various standards including Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice. It gives detailed explanations of how to prepare, update and maintain Standard Operating Procedures and also includes advice on training and development of personnel. This text is ideal for clinical trial monitors and quality assurance personnel in the pharmaceutical industry.

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Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, Second Edition

This edition is a valuable resource for all involved in the process development, manufacture, and registration of APIs. Eleven contributors with significant experience in the field deliver expert information you can use.

Revised and expanded coverage includes:

• Process development, manufacture, and registration of APIs with the basic therapeutic activity of most drug products – based on so-called small molecules, including drugs obtained by biosynthesis in fermentation processing
• New technology, business models, and regulatory expectations
• Chapters in biological manufacturing and aseptic processing that cover technologies and methods used in the majority small-molecule APIs and in the drugs in the biologicals category
• Thermochemical process safety, process safety at large, and environmental practices
• Drug regulatory affairs guidance that enables manufacturing compliance to increase across API manufacture