Good manufacturing practice system

As is usually the case, the need for analysis and characterisation does not stop once a devulcanisation process has been fully developed and commercialised, as it is important to carry out quality control checks at regular intervals as an integral part of any quality assurance and good manufacturing practice system. Carrying out such tests provides the purchasers of the devulcanised product with reassurance that the system is not only inherently capable of producing a high-quality product, but that it is also able to do this consistently over an extended period of time. 

Besides internal quaUty audits, there are audits conducted by external authorities for conformance to estabUshed quaUty systems. The two chief standards affecting the chemical industry are the U.S. Food and Dmg Administration Current Good Manufacturing Practice (GMP) regulation and the International Organization for Standardization ISO 9000 series. A quaUty system performance-related standard is the Malcolm Baldrige National QuaUty Award... 

A division s system for compliance with ISO 9000 and/or Good Manufacturing Practice requirements... 

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. ... 

Development studies are not normally considered to fall within the system of good manufacturing practice... 

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. 

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