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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).
If the firm markets other FDA-regulated products and the issue(s) affect marketed products—or the inspection extended to marketed products included on the FDA 483, then they may issue a Warning Letter These include the following statement: "Due to the deficiencies listed on the attached FDA 483 we are recommending to the center that approval ...
FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), [1] also known as the Office of Regulatory Affairs (ORA), [2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation ...
A person cannot, without a license or exception, export or re-export foreign-made commodities, software, or technology that incorporates controlled US-origin commodities, software, or technology if the items require a license and incorporate or are combined with more than a minimal amount of controlled US content, as defined in Title 15 of the ...
Third Party Certification The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for the FDA to recognize accreditation bodies is due 2 years after enactment)
An Export Management and Compliance Program (EMCP) is required by the U.S. Government to ensure that companies comply with export control policy for dual-use commodities, software, and technology. [1] The policies and regulations are intended to enhance national security; as well as limiting the proliferation of weapons of mass destruction.
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.
In its Guidance for Industry "Data Integrity and Compliance With Drug CGMP" US-FDA states “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues ...