EudraLex--The Rules Governing Medicinal Products in the European Union. Vol. 4. Good Manufacturing Practice (GMP) Guidelines. Annex 16: Certification by a Qualified Person and Batch Release, 2001, http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-m/v4_an16_20040...
The GMP rules regarding their quality control system The GMP rules regarding documentation The detailed GMP rules as established in the Annex General Product Safety Directive The General Product Safety Directive (GPSD) aims to ensure the safety of products placed on the market. It establishes general...
Sweeteners of natural sources, such as sugar alcohols, are in the centre of growing interest. Their impact on the phytochemicals, antioxidant and sensory p
A third laboratory, the Radioisotope Factory laboratory for radioisotope/radiopharmaceutical production, is foreseen in further years dedicated to the implementation of a laboratory for Good Manufacturing Practice (GMP) production of radiopharmaceuticals. Figure 3 shows a schematic layout of the upper floor,...
OP44 Implementation of a GMP-grade radiopharmacy facility in Maastricht Ivo Pooters, Maartje Lotz, Roel Wierts, Felix Mottaghy, Matthias Bauwens OP45 Setting up a GMP production of a new radiopharmaceutical Forsback, Sarita, Bergman Jörgen, Kivelä Riikka OP48 In vitro and in vivo evaluat...
The GMP is a system that aims at ensuring that products, such as food contact materials and articles, consistently conform, comply, and are produced following strict quality standards. If FCM is manufactured using good manufacturing practices, then the finished products are less likely to: ...
While 21 CFR part 11 is only applicable for electronic records, EU GMP Annex 11 is not limited to electronic documents. The EU system applies to software, hardware, risk management and personal. Despite their similarities, what you find is that both regulations are based on different regulatory...
1 Ensuring sterility of indirect product contacting surfaces 机译:在GMP提供清晰度:指导注释1 No.1确保间接产品接触表面的无菌性 作者:James Drinkwater 期刊名称:《European journal of parenteral & pharmaceutical sciences: the official journal of the ESPC》 | 2018年第4期 31.Rationale for the selection...
Manufacturers of such products need to have a detailed knowledge of their supply chain and their production processes, and they have to adhere to Good Manufacturing Practise (GMP) in order to correctly declare the presence of food allergenic ingredients like peanuts and hazelnuts (Stein et al., ...
Commission staff working document - annex to the : proposal for a regulation on advanced therapy medicinal products impact assessment {COM(2005) 567 final} /* SEC/2005/1444 */. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52005SC1444:en:HTML. Published November 16, 2005...