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Book Cover
Author Haider, Syed Imtiaz

Title Quality control training manual : comprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories / Syed Imtiaz Haider, Erfan Asif Syed
Published Boca Raton : CRC Press, 2011
Online access available from:
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Description 1 online resource (xxix, 456 pages) : illustrations
Contents Qct-01. Analytical methods, techniques and quality measures for general pharmaceutical products -- qct-02. Analytical methods, techniques and quality measures for biological products -- qct-03. Laboratory training manual -- qct-04. Assessment of training -- qct-05. Training assessment with quiz and answers -- qct-06. Training log -- qct-07. Analytical method validation master plan -- qct-08. Analytical methods validation protocol -- qct-09. SOP for annual re-qualification of HPLC units -- qct-10. SOP for annual re-qualification of GC units -- qct-11. ABC pharmaceutical company -- qct-12. Regulations
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"--Provided by publisher
Bibliography Includes bibliographical references and index
Subject Medical laboratories -- Standards
Pharmaceutical technology -- Standards
Medical laboratories -- Examinations, questions, etc
Pharmaceutical technology -- Examinations, questions, etc
Quality control.
Laboratories -- standards
Technology, Pharmaceutical -- standards
Biotechnology -- standards
Drug Industry -- standards
Pharmaceutical Preparations -- standards
Quality Control
quality control.
MEDICAL -- Pharmacology.
Medical laboratories.
Medical laboratories -- Standards.
Pharmaceutical technology.
Pharmaceutical technology -- Standards.
Genre/Form Electronic books
Form Electronic book
Author Asif, Erfan Syed
ISBN 9781439850169