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EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been ...
Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics. Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X
The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in 1979 in USA, to improve the quality of pharmaceuticals. [1] It was proposed in direct response to several problems in the sterility of large volume parenteral market.
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 ]
Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products.
Al Zein, a Syrian shawarma restaurant in Alpharetta, Georgia, is going viral for an ad so "brilliant'," people say they’re going to drive hours to try its food.
Stanley is recalling 2.6 million mugs sold in the U.S. after the company received dozens of consumer complaints, including some users who reported getting burned and requiring medical attention ...
3. Keebler Fudge Magic Middles. Neither the chocolate fudge cream inside a shortbread cookie nor versions with peanut butter or chocolate chip crusts survived.