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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 ...
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
Alsever's solution is a saline liquid used to prevent coagulation of blood. [ 1 ] [ 2 ] It is composed of 2.05% dextrose , 0.8% sodium citrate , 0.055% citric acid , and 0.42% sodium chloride . For usage, an equal volume of blood is gently, but thoroughly, mixed with the solution.
These glass food containers are over 40% off: 'I like them more than my Pyrex'
Heparin is an anticoagulant, and if used as a catheter lock solution it could leak into the blood circulation of the patient. Therefore it has been associated with catheter-related bleeding and heparin induced thrombocytopenia (HIT). [8] [9] Citrate catheter lock solutions are being used in three different concentrations – 4%, 30% and 46.7%.
Validol, the anxiety medication containing a roughly 25% solution of menthol in menthyl isovalerate is prepared essentially in one step, in which the amount of menthol added before conducting the acid catalysed esterification is in an excess such that the resulting solution of the yielded ester has around 25% menthol, simplifying the procedure.