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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.
Example pharmaceutical packaging line. All aspects of pharmaceutical production, including packaging, are tightly controlled and have regulatory requirements. Uniformity, cleanliness , sterility, and other requirements are needed to maintain Good Manufacturing Practices. Product safety management is vital.
The Site Master file contains specific and factual GMP information about the production and control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file needs to ...
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process.CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes.
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 ]
Equipment used in aseptic processing of food and beverages must be sterilized before processing and remain sterile during processing. [1] When designing aseptic processing equipment there are six basic requirements to consider: the equipment must have the capability of being cleaned thoroughly, it must be able to be sterilized with steam, chemicals, or high-temperature water, sterilization ...
"Water for Pharmaceutical Use". Inspection Technical Guides. U.S. Food and Drug Administration. 27 August 2014. "Guideline on the quality of water for pharmaceutical use (draft)" (PDF). 4 Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency (EMA). 13 November 2018. "Water for injection". Drug Information Portal. U.S ...
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...