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EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 - Pharmaceutical Legislation. Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines.
It was proposed in direct response to several problems in the sterility of large volume parenteral market. The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.
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 ...
The exact formula of Phos-Chek is not public knowledge but the company has said in previous filings that the product is 80% water, 14% fertiliser-type salts, 6% colouring agents and corrosion ...
The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and European Medicines Agency (EMA). EMA and the Member States cooperate and share expertise in the assessment of new ...
IARC group 2B substances, mixtures and exposure circumstances are those that have been classified as "possibly carcinogenic to humans" by the International Agency for Research on Cancer (IARC) as [1] This category is used when there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals.
Nicole Kidman is paying homage to her Babygirl character. While accepting the award for best actress at the National Board of Review Gala in New York City Tuesday, Jan. 7, the actress, 57 ...
Seidlitz powders is the generic name under which a commonly known laxative and digestion regulator was marketed and sold by numerous manufacturers under names such as "Rexall Seidlitz Powders", particularly in the late 19th and early 20th centuries.