Validation Standard Operating Procedures
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
2nd Edition
Syed Imtiaz Haider
CRC Press
Published May 30, 2006
Reference - 1144 Pages - 16 B/W Illustrations
ISBN 9780849395291 - CAT# 9529
Summary
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.
Table of Contents
Introduction to Validation. Fundamentals of Validation SOPs. Validation Glossary. Calibration of Instruments. Training on the Job. Guidelines for Area Classification and Air Handling. Validation of a Steam Sterilizer. Kneading Machine. Blistering Machine. Installation Qualification of Computerized Equipment. Validation of Microbiological Methods. Vendor Certification. Facility Qualification. Recommended Reading.
- 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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