Ad
related to: copp certificate of pharmaceutical product template excel sample data
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).
If certified cost or pricing data has been requested by the Government and submitted by an offeror, but an exception is later found to apply, the data should not be considered to be "certified". [1] The requirement for a certificate of cost or pricing data may also apply to sub-contractors at any tier in the supply chain. [2] [4]
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
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
A certificate of analysis (COA) is a formal laboratory-prepared document that details the results of (and sometimes the specifications and analytical methods for) one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses.
[[Category:Pharmaceutical company templates]] to the <includeonly> section at the bottom of that page. Otherwise, add <noinclude>[[Category:Pharmaceutical company templates]]</noinclude> to the end of the template code, making sure it starts on the same line as the code's last character.
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 ...
Ad
related to: copp certificate of pharmaceutical product template excel sample data