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  2. Pharmaceutical manufacturing - Wikipedia

    en.wikipedia.org/wiki/Pharmaceutical_manufacturing

    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.

  3. Critical process parameters - Wikipedia

    en.wikipedia.org/wiki/Critical_Process_Parameters

    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 .

  4. Process performance qualification protocol - Wikipedia

    en.wikipedia.org/wiki/Process_Performance...

    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.

  5. Process chemistry - Wikipedia

    en.wikipedia.org/wiki/Process_chemistry

    The process chemistry group at Boehringer Ingelheim, for example, targets a VTO of less than 1 for any given synthetic step or chemical process. Additionally, the raw conversion cost of an API synthesis (in dollars per batch) can be calculated from the VTO, given the operating cost and usable capacity of a particular reactor.

  6. Performance indicator - Wikipedia

    en.wikipedia.org/wiki/Performance_indicator

    KPI information boards. A performance indicator or key performance indicator (KPI) is a type of performance measurement. [1] KPIs evaluate the success of an organization or of a particular activity (such as projects, programs, products and other initiatives) in which it engages. [2]

  7. Process analytical technology - Wikipedia

    en.wikipedia.org/wiki/Process_analytical_technology

    The FDA has outlined a regulatory framework [1] for PAT implementation. 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 ...

  8. Validation (drug manufacture) - Wikipedia

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

    Validation process efforts must account for the complete product life cycle, including developmental procedures adapted for qualification of a drug product commencing with its research and development phase, rationale for adapting a best fit formula which represents the relationship between required outputs and specified inputs, and procedure ...

  9. Good automated manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_Automated...

    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. The second edition (GAMP5) was released in July 2022. [2]