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Current Good Manufacturing Practices (cGMPs)

Current Good Manufacturing Practices (cGMPs) are the current accepted standards of design, operation, practice, and sanitization. These are the standard guidelines set out by the FDA to ensure drug development is carried out in safe and quality processes, to avoid contamination and ensure repeatability. The FDA is empowered to inspect drug-manufacturing plants in which drugs are processed, manufactured, packaged, and stored for compliance with these standards. What are the 7 Deadly Sins of Quality Assurance and Quality Control? Find

Jan-Gunnar Gustafsson, VP of Process Development and Manufacturing, Baau Therapeutics Speaks to Pharma IQ

Jan-Gunnar Gustafsson Vice President, Process Development and Manufacturing, Baau Therapeutics AB, speaks to Andrea Charles from Pharma IQ, about contract manufacturing strategy, mitigating risk and approaches to CMO selection from a small...

Thu, 08/18/2011
Pharma IQ

In this Pharma IQ podcast, Diane Petitti, Vice President, Quality at Amylin Pharmaceuticals, speaks to Andrea Charles from Pharma IQ, about the current challenges relating to domestic and overseas outsourced manufacturing and how to determine the...

Contributor: Pharma IQ
Wed, 09/15/2010
Pharma IQ

Good manufacturing process (GMP) guidelines are essential to ensure drugs are produced to a consistently high quality. GMP guidelines should be implemented at all stages of the manufacturing process to eliminate the possibility of risks, that...

Contributor: Pharma IQ
Sun, 09/05/2010