enow.com Web Search

Search results

  1. Results from the WOW.Com Content Network
  2. Certificate of pharmaceutical product - Wikipedia

    en.wikipedia.org/wiki/Certificate_of...

    The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).

  3. Marketing authorisation - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation

    Depending on jurisdiction, the resulting document may be more detailed (in addition to data identifying the product and its marketing authorisation holder), for example containing addresses of all manufacturing sites, appended labelling, artwork of packaging components, etc. or may be simplified to a one-page document called certificate of ...

  4. 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. Those attributes with a higher impact on CQAs should be ...

  5. CPP - Wikipedia

    en.wikipedia.org/wiki/CPP

    Certificate of pharmaceutical product, a certificate which establishes the status of a pharmaceutical product; Chronic pelvic pain, a medical condition; Critical process parameters, key variables affecting the production process; Chronic pain patients, a medical group with multiple painful conditions

  6. Copp - Wikipedia

    en.wikipedia.org/wiki/Copp

    Certificate of pharmaceutical product, a certificate which establishes the status of a pharmaceutical product; COPP (chemotherapy), a chemotherapy regimen for treatment of non-Hodgkin lymphoma; COPP (Combined Operations Pilotage Parties), a defunct British special military unit; Copps Coliseum, a sports and entertainment venue in Hamilton, Ontario

  7. International Council for Harmonisation of Technical ...

    en.wikipedia.org/wiki/International_Council_for...

    In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.

  8. 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).

  9. Medication package insert - Wikipedia

    en.wikipedia.org/wiki/Medication_package_insert

    The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows: