Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

Syed Imtiaz Haider, Syed Erfan Asif

• Editorial: CRC Press
• Año: 2016
• ISBN:
  9781439850169
• Edición: 1
• Categoría: Medicine
• Categoría: Biotechnology in Medicine

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.

Índice

• Front Cover
• Contents
• Preface
• Acknowledgements
• Authors
• About the Book
• Disclaimer
• QCT-01 : Analytical Methods, Techniques and Quality Measures for General Pharmaceutical Products
• QCT-01.1: Analytical Method Validation and Requirements
• QCT-01.2: Laboratory Equipment
• QCT-01.2 : Laboratory Equipment
• QCT-01.3 : Reference Standards and Reagents
• QCT-01.4 - Sample Management
• QCT-01.5 - Stability Analytical Methods and Requirements
• QCT-01.6 - Microbiological Methods and Analysis
• QCT-01.7 - Analytical Failure Investigations
• QCT-01.8 - Calibration Program
• QCT-01.9 - Laboratory Facility
• QCT-01.10 - Products Annual Reviews
• QCT-01.11 - Third-Party Testing
• QCT-01.12 - Good Documentation Practices
• QCT-01.13 - Change Control
• QCT-02 - Analytical Methods, Techniques and Quality Measures for Biological Products
• QCT-02.1 - Immunoblotting
• QCT-02.2 - Gel Permeation Chromatography
• QCT-02.3 - Electrophoresis
• QCT-02.4 - Ion-Exchange Chromatography
• QCT-03 - Laboratory Training Manual
• QCT-03.1 - Laboratory Safety and Good Laboratory Practice
• QCT-03.2 - Training of Sampling Procedure
• QCT-03.3.1 - Training of Conventional Procedures
• QCT-03.3.2 - Training of Basic Analytical Techniques
• QCT-03.3.3 - Training of Chromatographic Techniques
• QCT-03.3.4 - Spectroscopic Techniques
• QCT-03.3.5 - Electrochemical Techniques
• QCT-03.3.6 - Dissolution Test
• QCT-03.3.7 - Miscellaneous Techniques
• QCT-04 - Assessment of Training
• QCT-04.1 - Assessment Procedure for Chemical Testing
• QCT-04.2 - Assessment Procedure for Microbiologist
• QCT-05 - Training Assessment with Quiz and Answers
• QCT-05.1 - Assessment for Analytical Methods Validation and Requirements
• QCT-05.1.1 - Answers to Quiz for Analytical Methods Validation and Requirements
• QCT-05.2 - Assessment for Analytical Equipment
• QCT-05.2.1 - Answers to Quiz for Analytical Equipment
• QCT-05.3 - Assessment for Reference Standards and Reagents
• QCT-05.3.1 - Answers to Quiz for Reference Standards and Reagents
• QCT-05.4 - Assessment for Sample Management
• QCT-05.4.1 - Answers to Quiz for Sample Management
• QCT-05.5 - Assessment for Stability Analytical Methods and Requirements
• QCT-05.5.1 - Answers to Quiz for Stability Analytical Methods and Requirements
• QCT-05.6 - Assessment for Microbiological Methods and Testing
• QCT-05.6.1 - Answers to Quiz for Microbiological Methods and Testing
• QCT-05.7 - Assessment for Laboratory Investigations
• QCT-05.7.1 - Answers to Quiz for Laboratory Investigations
• QCT-05.8 - Assessment for Calibration Programme
• QCT-05.8.1 - Answers to Quiz for Calibration Programme
• QCT-05.9 - Assessment for Laboratory Facility
• QCT-05.9.1 - Answers to Quiz for Laboratory Facility
• QCT-05.10 - Assessment for Annual Reviews
• QCT-05.10.1 - Answers to Quiz for Annual Reviews
• QCT-05.11 - Assessment for Third-Party Testing
• QCT-05.11.1 - Answers to Quiz for Third-Party Testing
• QCT-05.12 - Assessment for Good Documentation Practices
• QCT-05.12.1 - Answers to Quiz for Good Documentation Practices
• QCT-05.13 - Assessment for Change Control
• QCT-05.13.1 - Answers to Quiz for Change Control
• QCT-05.14 - Assessment for Immunoblotting
• QCT-05.14.1 - Answers to Quiz for Immunoblotting
• QCT-05.15 - Assessment for Gel Permeation Chromatography
• QCT-05.15.1 - Answers to Quiz for Gel Permeation Chromatography
• QCT-05.16 - Assessment for Electrophoresis
• QCT-05.16.1 - Answers to Quiz for Electrophoresis
• QCT-05.17 - Assessment for Ion-Exchange Chromatography
• QCT-05.17.1 - Answers to Quiz for Ion-Exchange Chromatography
• QCT-06 - Training Log
• QCT-06.1 - General Introduction Training Log
• QCT-06.2 - Good Housekeeping and Good Laboratory Practice
• QCT-06.3 - Sampling Procedure Training Log
• QCT-06.4 - Chemical Testing Training Log
• QCT-06.5 - Training Log for Microbiology
• 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
• QCT-12.1
• QCT-12.1
• QCT-12.2
• CLV-12.3
• QCT-12.4
• QCT-12.5
• Index
• Back Cover