A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Determination of drug permeability and prediction of drug 1033 absorption in caco2 monolayers. Ec iii224487en, 1989 usp xxiii, the united states pharmacopeia. Number 1, paris 1992 guide to good manufacturing practice for medicinal products. Zertifikate zertifikat iso9001 english haccp verordnung eg nr. European commission volume 4 of the rules governing medicinal easily convert pdf files to word mac products in the. The following guideline can be ordered through the address listed in the sourcepublishercategory. Ep 27 event tree analysis f 28 factory acceptance test fat 28 fault tree analysis 29 fda 29 fda guidance for industry process validation. Volume 4 of the rules governing medicinal products in the european union contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in commission directives 956eec, as amended by directive 200394ec, and 91412eec respectively. Modul name cell culture technology in semester 6th btb. Pdf should package leaflets be coloured in the future.
Good manufacturing practice medicinal products for human and veterinary use explanatory notes on the preparation of a site master file these notes are intended to provide guidance on the recommended content of the site master file. The paper version of the oj has legal value for ojs published before 1 july 20, the date regulation eu no 21620 entered into force. Eg leitfaden pic leitfaden picph 493 smf whorichtlinie fda cfr 211 oecdglp iso 9000 ff x. The urs should be a point of reference throughout the validation life cycle. A requirement for a site master file is referred to in chapter 4 of the gmp guide. Product specification file and the relevant clinical trial protocol as appropriate. The next element in the qualification of equipment, facilities, utilities, or systems is dq where the compliance of the design with gmp should be. Supplementary guidelines to the ecgmp guide with specific requirements for the. Good manufacturing practice medicinal products for human and veterinary use annex 1 manufacture of sterile medicinal products corrected version document history previous version dated 30 may 2003, in operation since september 2003 revision to align classification table of clean rooms, to include.
This document pro vides guidance for the interpretation of the prin ciples and guidelines of good manufacturing practice gmp for medicinal products as laid. Modul name cell culture technology in semester 6th btb modul code 602 etcs points 8 working hours. To verify the electronic signature and authentic character of the oj, download the pdf file of the eoj and its signature, then use checklex. The product specification file see glossary should be continually updated as development of the product proceeds, ensuring appropriate traceability to the previous versions.
This document is an excerpt from the eurlex website menu. Template for the written confirmation for active substances exported to the european union for medicinal products for human use version 2, january 20 guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared. A program designed to be specific to a food facility. Guidance on safety evaluation of nutrient sources and. Draft annex 15 v12 200115 for pics and ec adoption.
Eudralex volume 4 good manufacturing practice gmp guidelines. Key words eg gmp leitfaden, annex 1 qualifizierung validierung. Amendments to the text of chapter 1 have been made in order. The use of colour to emphasise important information and headings of package leaflets has been recommended in the readability guideline of the european union since 1998. Unter gute herstellungspraxis englisch good manufacturing practice, abgekurzt gmp. Other guidelines published by the european commission should be taken into account where relevant and as appropriate to the stage of development of the product. It should include, or refer to, the following documents. Replacement of commission directive 956ec of june 1991 to cover. Good manufacturing programshazard analysis critical control point a system which identifies specific hazards and preventative measures for their control programs to manage food safety.