Drug manufacturers have employed contamination control measures for decades as a core element of good manufacturing practices. Commonly, these are a collection of generic practices that were developed separately and applied without clear consideration for their interdependence.
The ongoing evolution of contamination control principles that this document addresses is a shift to a holistic approach, where the practices are designed to work together to achieve proactive contamination control and are evaluated for their collective effectiveness. The holistic approach also demands that contamination control measures be tailored to the specific risks around each individual process.
This document focuses on contamination control practices against microbial and other adventitious agents, endotoxins, and foreign particulate matter in the manufacture of sterile drugs, low bioburden drug substances, and some nonsterile drugs that are vulnerable to contamination.
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Table of Contents:
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- Glossary and Abbreviation
- Process Design,Microbial Control, and Monitoring
- Facilities and Utilities
- Raw Materials
- Environmental Control, Validation, and Monitoring
- Personnel Training and Qualification
- Equipment Design, Validation, and Ongoing Control
- Product Containers and Closures
- Quality Systems
- CCS Governance and Effectiveness Review