Final Version of Annex 15 to the EU Guide to. Good Manufacturing Practice. Title: Qualification and validation . First discussion in drafting group. Discussion at

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EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good . Annex 15. Qualification and validation (into operation since 1 October 2015). Annex The following guideline can be ordered through the address listed in the EU GMP Annex 15: Qualification and Validation. Short Title: Annex 15. Internet:. EU GMP Annex 15: Qualification and Validation. Kurztitel: Annex 15. Internet: www.gmp-compliance.org/guidemgr/files/2015-10_ANNEX15.PDF. Revised Annex 15 to PIC/S GMP Guide. Geneva, 13 April 2015: The PIC/S Committee has adopted by written procedure the revision of Annex 15 of the PIC/S 30 Mar 2015 EU Guidelines for. Good Manufacturing Practice for. Medicinal Products for Human and Veterinary Use. Annex 15: Qualification and Validation. 26 Apr 2016 The revision to Annex 15 takes into consideration changes to other of qualification and validation which are applicable to the facilities,6 Feb 2014 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Annex 15: Qualification and Validation. MKT_TMP200_01_r06. White paper: EU GMP Guide-Annex 15. Qualification & Validation draft released. In February 2014, a draft of the revised Annex 15 was. 8 Apr 2015 The currently valid version of the EU GMP Guide Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015.