Manufacture of pharmaceuticals

Medicinal Products - Manufacture - Guidelines

  Name En. v. Valid. since Replaces Amends
VYR-39 Licence for Safeguarding the Quality and Safety of Human Tissues   and Cells Intended for Use in Man No 30.1.2009 - -
VYR-36 Clean Rooms No 1.3.2009 - -
VYR-35 version 1 Procedure for licensing of manufacture of medicinal products and investigational medicinal products for the purpose of their import from third countries No 1.9.2008 VYR-35 -
VYR-34 Heat sterilisation processes No 1.8.2005 VYR-12 -
VYR-33 Ethylene oxide sterilization, sterilization by irradiation and estimation of the population of micro-organisms No 1.1.2005 - VYR-12
VYR-32 version 3 Guidelines for Good Manufacturing Practice No 1.12.2011 VYR-32 version 2 -
VYR-31 version 1 Issuing of GMP Certificates for Active Pharmaceutical Ingredients No 6.10.2008 VYR-31 -
VYR-30 version 1 Issuing of GMP Certificates for Medicinal Products No 1.9.2008 VYR-30 -
VYR-29 v1 Application for an authorisation/change to authorisation for manufacture of blood components and materials derived from blood and its components for further manufacture
(version 1)
No 1.9.2007 VYR-29 -
VYR-28 version 2 Application for an authorisation for activities of control laboratory, change to an authorisation for activities of control laboratory and guidance for provision of detailed information on activities No 1.9.2008 VYR-28 version 1 -
VYR-27 version 2 Application for an authorisation/change to authorisation for manufacture of medicinal products and guidance for provision of detailed information on manufacture No 1.9.2008 VYR-27 version 1 -
VYR-26 version 1 Guidelines for good manufacturing practice for active pharmaceutical ingredients No 12.3.2008 VYR-26 -
VYR-17 Shelf life extension of a batch of medicinal product manufactured before the approval of the appropriate variation to the registration Yes 1.7.2001 VYR-13 -
VYR-10 version 1 General Requirements of SUKL on Validation of Aseptic Procedures No 1.3.2009 - VYR-3 and (1)