Expertly leading readers through the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry, Validation Standard Operating Procedures:

• provides 139 ready-to-use Master Validation procedures, template protocols, and reports
• supplies a CD-ROM with a template of customizable validation standard operating procedures
• includes examples of 11 critical qualification and re-qualification reports
• presents 14 exclusive environmental performance evaluation procedures
• provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States
• includes step-by-step guidelines for translating GMP requirements into action

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, Validation Standard Operating Procedures 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, Validation Standard Operating Procedures Second Edition features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

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

Index

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