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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. [1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. [2]
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
Q9 may refer to: The fifth series of Q... (TV series) The IATA airline designator of Afrinat International Airlines; Q9 input method - an input method for Traditional Chinese text; Q9 (New York City bus) MQ-9 Reaper, an American unmanned aircraft. Quran 9, at-Tawbah the 9th chapter of the Islamic Holy book
I/O Controller Hub (ICH) is a family of Intel southbridge microchips used to manage data communications between a CPU and a motherboard, specifically Intel chipsets based on the Intel Hub Architecture. It is designed to be paired with a second support chip known as a northbridge. As with any other southbridge, the ICH is used to connect and ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The Q9 input method (Chinese: 九方輸入法), invented by Qcode Information Technology Ltd. of Hong Kong, is an input method that uses only the number keys on a numeric keypad to input Chinese characters into a digital device.
A fault tree diagram. Fault tree analysis (FTA) is a type of failure analysis in which an undesired state of a system is examined. This analysis method is mainly used in safety engineering and reliability engineering to understand how systems can fail, to identify the best ways to reduce risk and to determine (or get a feeling for) event rates of a safety accident or a particular system level ...