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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).
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 ]
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products.
The South African National Accreditation System (SANAS) is the official laboratory accreditation body for South Africa. Founded in 1996, SANAS is headquartered in Pretoria, South Africa . SANAS accreditation certificates are a formal recognition by the Government of South Africa that an organisation is competent to perform specific tasks.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
Granted after an assessment of the documentation submitted by the applicant, a Certificate of Suitability (CEP) [18] provides proof that the methods used by a manufacturer or distributor result in an product whose quality complies with the requirements laid down in the corresponding Ph. Eur. monograph(s). The EDQM also runs an inspection ...
to the end of the template code, making sure it starts on the same line as the code's last character. Pages in category "South Africa stub templates" The following 106 pages are in this category, out of 106 total.
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