Method Validation in Pharmaceutical Analysis
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
Editor(s): Dr. Joachim Ermer Dr. John H. McB. Miller
First published:5 August 2005
Print ISBN:9783527312559 |Online ISBN:9783527604685 |DOI:10.1002/3527604685
Copyright © 2005 Wiley‐VCH Verlag GmbH & Co. KGaA
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness.
Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.
With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
- Hospitals and Pharmacies | Fundamental sciences | Community Pharmacy | Selling and Marketing in Pharmacies | Essential Soft Skills | Management | Accounting | Legal affairs | Hospital pharmacy | Clinical pharmacy | Quality Control | Infection control | Storage | Mathematics
- Pharmaceutical Industry | Regulatory Agency Governance | Quality Systems | Laboratory Systems | Infrastructure: Facilities, Utilities, Equipment | Materials and Supply Chain Management | Sterile and Nonsterile Manufacturing Systems | Filling, Packaging, Labeling | Product Development and Technology Transfer | Safety and occupational health | Environmental safety | Pharmaceutical Validation
- Selling and Marketing | Selling skills | Marketing planning | Human Resources | Medical updates | Training skills | Regulatory affairs | Pharmacovigilance | Information Technology
- validation (43) | Cleaning Validation (10) | GMP (8) | Process Validation (8) | Computer System Validation (8) | Equipment Validation (7) | Arabic (7) | Equipment Management (6) | FDA (6) | WHO (5) | Analytical Method Validation (5) | Quality Assurance (3) | manufacturing (3) | formulation (3) | World Health Organization (2) | PIC/S (2) | HVAC (2) | Utilities (2) | synthetic (2) | sterile (2) | Community (2) | day (1) | Pharmacy (1) | European Medicines Agency (1) | factory (1)
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