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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.
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 desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union. [1]
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In the first attack, on Sept. 29, 2009, Muller allegedly broke into a woman’s home in Mountain View, tied her up, forced her drink a mix of medications and told her he was going to rape her ...
A massive power outage blanketed most of Puerto Rico early Tuesday, leaving more than 1.2 million people without electricity. Here's what to know about the blackout and Luma Energy, which handles ...
While each document (and each language version) is an individual part of the database, the content is grouped into sectors. There are currently 12 sectors, each represented by a number or a letter: [10] 1 - Treaties; 2 – International agreements; 3 – Legal acts; 4 – Complementary legislation; 5 – Preparatory documents; 6 – Case-law