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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.
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
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.
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 ]
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.
"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 ...
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations , such as milling , granulation , coating , tablet pressing , and others.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.