In cases in which you can order through the internet we have established a hyperlink. European commission enterprise and industry directorategeneral consumer goods pharmaceuticals brussels, 25 november 2008 rev. Annex 15 qualification and validation annex 11 computerised systems annexes for specific products, e. Annex 2 is no longer applicable to advanced therapy medicinal products to which applies the commission guideline on good manufacturing practice for advanced therapy medicinal products, published in part iv of. Gmpz herziening 2018 annex 15 kwalificatie en validatie nvza. Where a computerised system replaces a manual operation, there should be no. The current version of annex 15 of the eu guide to gmp was originally published in september. The tga has now legislated version of the pics guide to gmp for medicinal. Pics guide to gmp pe009 key changes to annex 15 qualification and validation. This change to annex 15 takes into account changes to other sections of the eu gmp guide part i, annex 11, ich q8, q9, q10 and q11, qwp guidance on process validation and changes in manufacturing technology.
The efficacy of any new procedure should be validated, and the. Eu gmp requirements biological medicinal product for human use dr. Eu gmp requirements biological medicinal product for human use. Draft annex 15 v12 200115 for pics and ec adoption. In deze herziening van annex 15 wordt rekening gehouden met. Practice gmp guidelines, that apply to the manufacturing of medicinal products aimed to. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these. New manufacture of biological active substances and medicinal products for human use into operation since 26 june 2018. Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. Martin melzer 15 staatliches gewerbeaufsichtsamt hannover european pharmacopoeia. Where validation protocols and other documentation are supplied by a third party. Part ii basic requirements for active substances ich q7 annexes, e.
Update as per concept paper on revision of annex 15. Eu gmp annex 2 part b specific guidance on selected product types allergens. Annex 18 gmp guide for active pharmaceutical ingredients. The following guideline can be ordered through the address listed in the sourcepublishercategory.
Annex 15 principle new text impact it is a gmp requirement that manufacturers. Martin melzer gmp training course 2021 october 2009. Filtration of medicinal products which cannot be sterilised in their final. Since annex 15 was published in 2001 the manufacturing and.
There are also associated changes to eu gmp chapter 4 documentation. Pics guide to gmp pe009 key changes to annex 15 tga. Eudralex the rules governing medicinal products in the european union volume 4 eu guidelines to good manufacturing practice medicinal products for human and veterinary use annex 1. New revised eu gmp annex 11 ispe international society. The efficacy of any new procedure should be validated, and the validation. The rules governing medicinal products in the european union volume 4 eu guidelines for.
The pics revised annex 15 can be downloaded from the link below. Guide to good manufacturing practice for medicinal products annexes. This change to annex 15 takes into account changes to other sections of the eugmp guide part i, annex. On the 30th of march, the eu released its updated version of annex 15 qualification and validation which will be effective on 01 october. The pics committee has adopted by written procedure the revision of annex 15 of the pics gmp guide which will enter into force on 1 october 2015, simultaneously to the eu revision of annex 15.
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