WATER REFERENCES – WHO Technical Report Series, No. 929, 2005. Annex 3 - WHO Good Manufacturing Practices: water for pharmaceutical use. http://apps.who.int/prequal/info_general/documents/trs929/who_trs_929.pdf TRS 970 Annex 2 WHO good manufacturing practices: water for ® pharmaceutical use. 2012 http://apps.who.int/medicinedocs/en/m/abstract/Js19832en/ TRS 937, Annex 4 Supplementary guidelines on good manufacturing practices: validation. 2006. ® -Appendix 2: Validation of water systems for pharmaceutical use FDA GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS.1993. http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074905.htm ASME BPE-2009 (Revision of ASME BPE-2007) Bioprocessing Equipment. ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated – Facilities Vol. 4 Water & Water Systems.2001 – – ISPE Baseline Guide, Volume 5, Commissioning and Qualification. 2001. ® USP <1231> WATER FOR PHARMACEUTICAL PURPOSES. PI 009-X Inspection of Utilities- Aide Memoire- PICS (PI 009-3, September ® 2007). Practical guidelines for qualifying purified water systems. Dec 01, 2007. A. ® Hultqvist. Pharmaceutical Technology Europe. Vol. 19, Issue 12. HVAC - REFERENCES WHO Technical Report Series, No. 937, Annex 4. Supplementary guidelines on good manufacturing practices validation. 2006. 1: Validation of –Appendix ® heating, ventilation and air-conditioning systems.
WATER – REFERENCES WHO Technical Report Series, No. 929, 2005. Annex 3 - WHO Good Manufacturing Practices: water for pharmaceutical use. http://apps.who.int/prequal/info_general/documents/trs929/who_trs_929.pdf TRS 970 Annex 2 WHO good manufacturing practices: water for pharmaceutical use. 2012 ® http://apps.who.int/medicinedocs/en/m/abstract/Js19832en/ TRS 937, Annex 4 Supplementary guidelines on good manufacturing practices: validation. 2006. -Appendix 2: Validation of water systems for pharmaceutical use ® FDA GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS.1993. http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074905.htm ASME BPE-2009 (Revision of ASME BPE-2007) Bioprocessing Equipment. ISPE Baseline – Pharmaceutical Engineering Guide for New and Renovated Facilities – Vol. 4 – Water & Water Systems.2001 ISPE Baseline Guide, Volume 5, Commissioning and Qualification. 2001. USP <1231> WATER FOR PHARMACEUTICAL PURPOSES. ® PI 009-X Inspection of Utilities- Aide Memoire- PICS (PI 009-3, September 2007). ® Practical guidelines for qualifying purified water systems. Dec 01, 2007. A. Hultqvist. Pharmaceutical Technology Europe. Vol. 19, Issue 12. ® HVAC - REFERENCES WHO Technical Report Series, No. 937, Annex 4. Supplementary guidelines on good manufacturing practices validation. 2006. –Appendix 1: Validation of heating, ventilation and air-conditioning systems. ®
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