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Full Description
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management.
Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues
Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements
Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries
Includes downloadable resources with downloadable training courses that can be adopted and directly customized to a particular organization
Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate
The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.
Contents
Preface. Analytical Methods, Techniques and Quality Measures for General Pharmaceutical Products. Analytical Methods and Techniques for Biological Products. Laboratory Training Manual. Assessment of Training. Training Assessment with Quiz and Answers. Training Log. Analytical Method Validation Master Plan. Analytical Methods Validation Protocol. SOP for Annual Re-Qualification of HPLC Units. SOP for Annual Re-Qualification of GC Units. ABC Pharmaceutical Company. Regulations. Index.
