Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories By Syed Imtiaz Haider, Syed Erfan Asif

Features

• Identifies local and international regulatory compliances
• Includes end-of-chapter questions on various elements used in quality control labs
• Provides training manuals and training log
• Contains ready-to-use Method Validation Master Plan templates
• Includes a CD-ROM that provides additional material

Summary

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 CD-ROM 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 a CD 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 CD supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

Table of 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