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Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality ...
Through the implementation of established and routine quality assurance programs, two primary functions are fulfilled: the determination of quality, and the control of quality. By monitoring the accuracy and precision of results, the quality assurance program should increase confidence in the reliability of the reported analytical results ...
With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.
Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001. [8] Probably the best known industry guidance available is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). [9]
QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations.
The industry's various subdivisions include distinct areas, such as manufacturing biologics, which are all subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceutical market produced treatments worth a total of $1,228.45 billion in 2020.