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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 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).
Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines. Concerning Medicinal Products for human use in clinical trials (investigational medicinal products). Volume 10 - Clinical trials. Concerning Veterinary Medicinal Products: Volume 5 - Pharmaceutical Legislation.
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 ]
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug Administration expectations for good manufacturing practice (GMP) compliance of manufacturing and related systems. [4] GAMP published its first guidance in 1994.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Good manufacturing practice (GMP) Best practice; American National Standards Institute (ANSI) Institute of Electrical and Electronics Engineers (IEEE) European Medicines Agency (EMEA) Food and Drug Administration (FDA) Ministry of Health, Labour and Welfare (Japan) Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation ...
As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.