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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices; ISO 22717:2015 Cosmetics – Microbiology – Detection of Pseudomonas aeruginosa; ISO 22718:2015 Cosmetics – Microbiology – Detection of Staphylococcus aureus
The historical pharmaceutical QMS applies primarily to good manufacturing practice as described in existing ISO (International Organization for Standardization) and ICH (International Committee on Harmonization) guidelines. "Good Manufacturing Practices (GMP) relate to quality control and quality assurance enabling companies in the ...
Other changes in this edition are the inclusion for the first time of general Good Manufacturing Practices (GMP) guidelines for food chemicals, and the abandonment of a previous policy whereby the specifications for individual substances applied also to mixtures of the primary substance with additives such as anticaking agents, antioxidants and ...
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
ISO 15378:2017 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) ISO 15394:2009 Packaging - Bar code and two-dimensional symbols for shipping, transport and receiving labels
It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects. [2] Food and Drug Administration inspectors often look at VMPs during audits to see whether or not a facility's validation strategy is well thought-out and organized.