Pharmaceutical CGMP

Learn How to Ensure Your Pharmaceutical Quality System Complies with CGMP Regulations

In 1978, when the Current Good Manufacturing Practice (CGMP) regulations were last revised, there were no cell phones, laptop computers, or Internet. Technology has changed so much since that the FDA deemed it necessary to address issues pertaining to modern quality systems.

The agency issued "A Guidance on Quality Systems Approach to Pharmaceutical CGMP" on September 29, 2006 to focus on changes brought about by technological advances in manufacturers' quality systems. While the FDA encourages modernization, it also wants to make sure that manufacturers are compliant with CGMP (21 CFR Parts 210 and 211) and to harmonize CGMP with other quality systems, such as ISO 9000, non-U.S. pharmaceutical quality management requirements, and the FDA's own medical device Quality System Regulation.

Watch Videos How MasterControl Makes Your Job Easier (3:50) Using MasterControl for FDA Compliance (3:53) A.P. Pharma (10:23)

These white papers cover the following:

• Validation realities;
• FDA's expectations regarding software validation;
• The GAMP4 model framework for validation;
• Risk-based assessment and risk management plans; and
• Transitioning to an electronic process.
• MasterControl Document Control module.
• MasterControl validation services.