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  2. QA/QC - Wikipedia

    en.wikipedia.org/wiki/QA/QC

    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.

  3. Validation (drug manufacture) - Wikipedia

    en.wikipedia.org/wiki/Validation_(drug_manufacture)

    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]

  4. Process analytical technology - Wikipedia

    en.wikipedia.org/wiki/Process_analytical_technology

    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.

  5. Quality assurance - Wikipedia

    en.wikipedia.org/wiki/Quality_assurance

    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 ...

  6. Pharmaceutical industry - Wikipedia

    en.wikipedia.org/wiki/Pharmaceutical_industry

    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.

  7. Pharmaceutical engineering - Wikipedia

    en.wikipedia.org/wiki/Pharmaceutical_engineering

    Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs.

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