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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).
The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [3]
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 Certification procedure [17] is not compulsory: it is a service that is offered to manufacturers who can submit their CEP [18] in the quality section of a new marketing authorisation (MA) application or a variation of an existing MA. It serves to centralise the evaluation of data for the benefit of both regulatory authorities and industry ...
The International Organization for Standardization (ISO / ˈ aɪ s oʊ / [3]) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. [4]
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
Investigators are trying to determine how a woman got past multiple security checkpoints this week at New York’s JFK International Airport and boarded a plane to Paris, apparently hiding in the ...
ISO 22000 is the most popular voluntary food safety international standard in the food industry with 51,535 total number of sites (as per the ISO Survey 2022).The ISO 22000 family are international voluntary consensus standards which align to Good Standardization Practices (GSP) [3] and the World Trade Organization (WTO) Principles for the Development of International Standards. [4]