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The Food and Drug Administration ( FDA) of the Philippines, formerly the Bureau of Food and Drugs ( BFAD / ˈbiːfæd /; 1982–2009), is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the "Food, Drugs and Devices, and Cosmetics Act", and subsequently reorganized by Republic Act No ...
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through ...
The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country. [2] Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory ...
The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements. For instance, a regulatory agency (such as CE or FDA) may ...
Verification and validation. Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000.
Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).
The National Medical Products Administration ( NMPA; [1] 国家药品监督管理局) is a national bureau responsible for drug supervision under the State Council of China and is managed by the State Administration for Market Regulation .
The International Certificate of Vaccination or Prophylaxis ( ICVP ), also known as the Carte Jaune or Yellow Card, is an official vaccination report created by the World Health Organization (WHO). [1] As a travel document, it is a kind of medical passport that is recognised internationally and may be required for entry to certain countries where there are increased health risks for travellers ...