Quality Systems for Drugs and Biologics
In 2002, the US Food and Drug Administration publicly recognized a need for change with its current good manufacturing practices (CGMP) for the 21st century initiative (1). This new approach to GMP compliance and enforcement recognized that FDA and the drug and biologics industries were not where they needed to be in terms of quality, manufacturing science, and risk management. This changing world of GMP applied to human and veterinary drugs and biological drug products. Key to FDA's approach has been to request a holistic cradle-to-grave management of quality issues.
Quality system: What is it?
The quality system should be an integrated framework within which the design, manufacture, packaging, labeling, and distribution take place. Commitment from management is crucial; without it there is no quality system. The underlying principles are:
Journal:
Pharmaceutical Technology, Feb 2, 2008
Copyright:
© Advanstar Communications, Inc. All rights reserved.
Full Article Link:
Quality Systems for Drugs and Biologics
It gives us an exhaustive description on Quality Systems for Drugs and Biologicals, It starts with the definition of Quality, describes about design control, FDA's vision about the quality issues, Risk management and so much, just read the chapter to prepare for an discussion on this topic. Really an good, simple yet detailed article.