Good Manufacturing Practice quality system

Good manufacturing practice See Quality system regulation. 

Quality system regulation The past good manufacturing practice (GMP) and process validation (PV) was renamed to quality system regulation (QSR). It is important for the medical device industry (that uses an extensive amount of plastics) and also in other product industries where they want to follow strict processing procedures. It sets up an important procedure for many plastic fabricators to consider that targets to ensure meeting zero defects. 

All stages of antibiotic manufacture from fermentation through to finished product are governed by the code of good manufacturing practice (GMP), of whieh quality eontrol is one aspect. GMP requires that there should be a eomprehensive system, so designed, documented, implemented and controlled, and so furnished with personnel, equipment and other resourees as to provide assuranee that products will consistently be of a quality appropriate to their intended use. ... 

One of the alternative approaches under the 510(k) paradigm is Special 510(k) Device Modifications. This approach utilizes certain aspects of the Quality System Regulations (Quality System Requirements for Good Manufacturing Practices). The other alternative is the Abbreviated 510(k). This approach utilizes special controls in which standards or voluntary guidelines can facilitate 510(k) review and expedite evaluation. 

Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics... 

Draft Guidance for Industry Quality System Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. FDA, September 2004. 

GUIDANCE FOR INDUSTRY QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS... 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

U.S. Food and Drug Administration (FDA) (2004), Guidance for industry Quality systems approach to pharmaceutical good manufacturing practice regulations, FDA, Rockuille, MD. 

Microparticulate Systems for the Delivery of Proteins and Vaccines, edited by Smadar Cohen and Howard Bernstein Good Manufacturing Practices for Pharmaceuticals A Plan for Total Quality Control, Fourth Edition, Revised and Expanded, Sidney H. Willig and James R. Stoker... 

A quality assurance system usually involves a matrix of written procedures. Good manufacturing practices (GMPs) are thus frequently equated with quality assurance systems. By similar lines of reasoning, validation, quality assurance, and GMPs are often associated with each other and even occasionally treated synonymously. 

U.S. Food and Drug Administration. Medical devices current good manufacturing practice (CGMP). Fed Reg Part 820, Quality System Regulation. Rockville, MD (1996). 

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