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June 15, 2009

Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commerical Manufacturing
Sponsored by: CDC Software
Content Type: White Paper
Our experience shows that early adoption of GMP (Good Manufacturing Practices) by a company, can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, in-house or out-sourced. The interpretation of compliance regulations, and subsequent recommendations in this document, are a compilation of years of experience and best practices from leading bio/pharmaceutical companies.
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Meeting Regulations, and Achieving Effective Microbial Control for Pharmaceutical Manufacturers
Sponsored by: MicroTest
Content Type: White Paper
Programs that meet regulatory compliance standards for industrial sterilization and contamination control are critical to the manufacture of pharmaceuticals. This white paper reviews the key elements of a best-practices environmental testing program, including U.S. FDA requirements, sterilization standards, proper certification and validation processes, and other critical factors in maintaining controlled environments.
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Tackling the Challenges of Pharmaceutical Manufacturing Productivity
Sponsored by: Parsec Automation
Content Type: White Paper
Pharmaceutical manufacturing operations are complex, inefficient and consequently costly, often exceeding the cost of research and development. This white paper explores the tools in the PAT framework, and shows how an appropriate combination of these tools may be applicable to a single-unit operation, or an entire manufacturing process in its quality assurance.
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