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PRINCIPLES OF CURRENT GOOD MANUFACTURING AND REGULATORY PRACTICE
Written by Administrator   

The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System (QS) regulation are promulgated under section of the Food, Drug and Cosmetic (FD&C) Act. They require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.

The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.

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ISO and IAF announce schedule for implementation of accredited certification to ISO 9001:2008
Written by Purdianta   
SO (International Organization for Standardization) and the IAF (International Accreditation Forum) have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008, the latest version of the world's most widely used standard for quality management systems (QMS). The details of the plan are given in the joint communiqué by the two organizations which appears below.
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The Compatibility Of Food Safety System with Quality Management System Certification
Written by Rosyidin   

Hazard Analysis and Critical Control Point (HACCP) certification is synonymous with food safety. HACCP is a food safety risk management system that addresses biological, chemical and physical hazards through anticipation and prevention rather than by a finished product inspection. The Good Manufacturing Practice (GMP), or Good Hygiene Practice (GHP), or Good Agriculture Practice (GAP) certifications are required prerequisites program for an effective HACCP system.

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