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  2. Clinical quality management system - Wikipedia

    en.wikipedia.org/wiki/Clinical_Quality...

    Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...

  3. Validation (drug manufacture) - Wikipedia

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

    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 variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

  4. Good manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_manufacturing_practice

    Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

  5. Good clinical practice - Wikipedia

    en.wikipedia.org/wiki/Good_clinical_practice

    Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines [1] include protection of human rights for the subjects and volunteers in a clinical trial. It also ...

  6. 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).

  7. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)

  8. Certificate of analysis - Wikipedia

    en.wikipedia.org/wiki/Certificate_of_analysis

    For example, regulations, standards, and/or guidelines affect COA use in agriculture, [2] [3] chemical, [4] [5] clinical research, [6] [7] food and beverage, [8] [9] and pharmaceutical [6] [7] [10] [11] industries. The COA may be used as a certification of product quality, an identification document, or a comparison document, depending upon the ...

  9. Quality assurance - Wikipedia

    en.wikipedia.org/wiki/Quality_assurance

    The terms "quality assurance" and "quality control" are often used interchangeably to refer to ways of ensuring the quality of a service or product. [3] For instance, the term "assurance" is often used in a context such as: Implementation of inspection and structured testing as a measure of quality assurance in a television set software project ...