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  2. Change control - Wikipedia

    en.wikipedia.org/wiki/Change_control

    Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal [1] —used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without ...

  3. Process analytical technology - Wikipedia

    en.wikipedia.org/wiki/Process_analytical_technology

    Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).

  4. Good automated manufacturing practice - Wikipedia

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

    More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...

  5. Validation (drug manufacture) - Wikipedia

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

    The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...

  6. Good documentation practice - Wikipedia

    en.wikipedia.org/wiki/Good_documentation_practice

    Avoiding asterisks as part of the notation of a hand-change – where insufficient white space permits a fully notated hand change, a common practice is to use an asterisk (or other mark) near the correction, and elsewhere record the same mark and the notation. The risk is that additional changes are made by another person who uses the same ...

  7. Continued process verification - Wikipedia

    en.wikipedia.org/wiki/Continued_process_verification

    In 2011 the Food and Drug Administration published a report [1] outlining best practices regarding business process validation in the pharmaceutical industry. Continued process verification is outlined in this report as the third stage in Process Validation.

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  9. Zamzar - Wikipedia

    en.wikipedia.org/wiki/Zamzar

    [7] Users can type in a URL or upload one or more files (if they are all of the same format) from their computer; Zamzar will then convert the file(s) to another user-specified format, such as an Adobe PDF file to a Microsoft Word document. [8] Once conversion is complete, users can immediately download the file from their web browser. [9]

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