Adding Value by Integrating cGMP with an ISO 9000 Quality Management System

Written by: John MacLauchlan, Quality Systems, Impact Analytical

Everyone who works in the Pharmaceutical industry lives and breathes compliance with Current Good Manufacturing Practices (cGMP) as part of their everyday work practices. The FDA1 are beginning to expect companies to also have comprehensive Quality Systems. These are now required under 21 CFR Part 820 for Medical Device Manufacturers, and more recently being discussed as becoming a requirement under 21 CFR Part 58, Good Laboratory Practices.

There can be significant value in integrating an overall Quality Management System (QMS) with compliance to regulations such as 21 CFR Part 210 and 211. The QMS is a formalized system of the Plan-Do-Check-Act process for continuous improvement. The QMS provides a framework in which supporting systems such as Planning, Purchasing, Information Technology, Corrective and Preventive Actions and Change Management work in concert to ensure all activities related to key process inputs and outputs are focused on timely, successful and increasingly more effective delivery of products that meet all stakeholder requirements. PLEASE CLICK BELOW TO DOWNLOAD FULL PAPER


 

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