Validation and Qualification in Analytical Laboratories
Validation and Qualification in Analytical Laboratories 2nd Edition
by Ludwig Huber (Author)
Publisher: CRC Press; 2 edition (July 23, 2007)
Language: English
ISBN-10: 084938267X
ISBN-13: 978-0849382673
This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.
- 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) | HVAC (2) | PIC/S (2) | Utilities (2) | synthetic (2) | sterile (2) | Community (2) | day (1) | Pharmacy (1) | European Medicines Agency (1) | factory (1)
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