Regulatory Inspection Of The Implementation Of Quality Assurance Programmes

Guidance in the organization and performance of regulatory inspection functions regarding the implementation of quality assurance programmes in all stages of the nuclear power plant project. The manual is intended primarily for the management personnel and upper staff from regulatory bodies but it will also be helpful to management personnel from nuclear utilities and vendors.

Over the years, the World Health Organization's Expert Committee on Specifications for Pharmaceutical Preparations, originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control for national regulatory and control systems and the implementation of international standards, but for the most part they have only been available in the annexes to various technical reports. In this second of two volumes, those annexes providing guidelines related to good manufacturing practices and to inspection of manufacturers and drug distribution channels have been gathered and revised. Annotation : 2004 Book News, Inc., Portland, OR (booknews.com).

A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development