Gmp Annex 1 Revision 2008, Interpretation Of Most Important Changes For The Manufacture Of Sterile Medicinal Products
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Publicado: 8 de agosto de 2012
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
PI 032-2 8 January 2010
RECOMMENDATION
GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS
© PIC/S January 2010 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source isacknowledged.
Editor: e-mail: web site:
PIC/S Secretariat info@picscheme.org http://www.picscheme.org
PI 032-2
1 of 11
8 January 2010
Index
0. 1. 2. 2.1 2.2 2.3 3. 4. 4.1 4.2 4.3 4.4 4.5 4.6 5. Document history............................................................................................... 2 Purpose and scope............................................................................................ 2 Basics ................................................................................................................ 3 Legal requirements (binding) ............................................................................. 3 Regulatory guidance (to be justified if not applied) ............................................. 3 Relevant international norms(to be justified if not applied) ................................ 3 Definitions and abbreviations ............................................................................. 3 New texts and their interpretation....................................................................... 4 Clean room / clean air device classification........................................................ 4 Clean room /clean air device monitoring ........................................................... 5 Microbiological monitoring.................................................................................. 7 Media simulations .............................................................................................. 7 Pre-sterilisation bioburden monitoring................................................................ 7 Provisions for environmental conditions for the handling of aseptically filled vials after leaving the aseptic processing area up until final sealing................... 8 Revision history ............................................................................................... 11
0. Document history
The present technical interpretation of Annex 1 to the PIC/S GMPGuide (PE 009) on the manufacture of sterile medicinal products (hereinafter referred to as GMP Annex 1) was initially drafted by Switzerland / Swissmedic and then commented by PIC/S Participating Authorities. It was agreed that the technical interpretation of GMP Annex 1 should be the same between the EU and PIC/S 1. Adoption by Committee of PI 032-1 Entry into force of PI 032-1 Entry into force ofPI 032-2 3 November 2009 1 December 2009 1 January 2010
1. Purpose and scope
In order to assure a harmonised conduct of inspections, with respect to the 2008 revision of GMP Annex 1 2, this document summarises the interpretations which an inspector of the competent regulatory authority should adopt when performing an inspection of a manufacturer of sterile medicinal products. This documentreflects the most important changes and also addresses the feedback from industry concerning the GMP Annex 1 Revision. It is not meant to address all changes within the Revision.
1
Annex 1 of the PIC/S GMP Guide is identical to Annex 1 of the EU GMP Guide (Eudralex Volume 4 GMP). Both Guides are equivalent in terms of GMP requirements. 2 The revision of Annex 1 to PIC/S GMP Guide was adopted on12 November 2008 by the PIC/S Committee and entered into force on 1 March 2009. PI 032-2 2 of 11 8 January 2010
2. Basics
2.1 Legal requirements (binding) • Refer to national legislation 3
2.2 Regulatory guidance (to be justified if not applied) • • For EEA countries: Eudralex Volume 4 GMP, GMP Annex 1, revision of November 25th, 2008 For non-EEA countries: PIC/S GMP Guide (PE 009),...
PI 032-2 8 January 2010
RECOMMENDATION
GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS
© PIC/S January 2010 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source isacknowledged.
Editor: e-mail: web site:
PIC/S Secretariat info@picscheme.org http://www.picscheme.org
PI 032-2
1 of 11
8 January 2010
Index
0. 1. 2. 2.1 2.2 2.3 3. 4. 4.1 4.2 4.3 4.4 4.5 4.6 5. Document history............................................................................................... 2 Purpose and scope............................................................................................ 2 Basics ................................................................................................................ 3 Legal requirements (binding) ............................................................................. 3 Regulatory guidance (to be justified if not applied) ............................................. 3 Relevant international norms(to be justified if not applied) ................................ 3 Definitions and abbreviations ............................................................................. 3 New texts and their interpretation....................................................................... 4 Clean room / clean air device classification........................................................ 4 Clean room /clean air device monitoring ........................................................... 5 Microbiological monitoring.................................................................................. 7 Media simulations .............................................................................................. 7 Pre-sterilisation bioburden monitoring................................................................ 7 Provisions for environmental conditions for the handling of aseptically filled vials after leaving the aseptic processing area up until final sealing................... 8 Revision history ............................................................................................... 11
0. Document history
The present technical interpretation of Annex 1 to the PIC/S GMPGuide (PE 009) on the manufacture of sterile medicinal products (hereinafter referred to as GMP Annex 1) was initially drafted by Switzerland / Swissmedic and then commented by PIC/S Participating Authorities. It was agreed that the technical interpretation of GMP Annex 1 should be the same between the EU and PIC/S 1. Adoption by Committee of PI 032-1 Entry into force of PI 032-1 Entry into force ofPI 032-2 3 November 2009 1 December 2009 1 January 2010
1. Purpose and scope
In order to assure a harmonised conduct of inspections, with respect to the 2008 revision of GMP Annex 1 2, this document summarises the interpretations which an inspector of the competent regulatory authority should adopt when performing an inspection of a manufacturer of sterile medicinal products. This documentreflects the most important changes and also addresses the feedback from industry concerning the GMP Annex 1 Revision. It is not meant to address all changes within the Revision.
1
Annex 1 of the PIC/S GMP Guide is identical to Annex 1 of the EU GMP Guide (Eudralex Volume 4 GMP). Both Guides are equivalent in terms of GMP requirements. 2 The revision of Annex 1 to PIC/S GMP Guide was adopted on12 November 2008 by the PIC/S Committee and entered into force on 1 March 2009. PI 032-2 2 of 11 8 January 2010
2. Basics
2.1 Legal requirements (binding) • Refer to national legislation 3
2.2 Regulatory guidance (to be justified if not applied) • • For EEA countries: Eudralex Volume 4 GMP, GMP Annex 1, revision of November 25th, 2008 For non-EEA countries: PIC/S GMP Guide (PE 009),...
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