Search results
Results from the WOW.Com Content Network
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).
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 ...
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 ...
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
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
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.
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).
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: