CLEAN ROOM & PHARMA

The official ref. and Guide Lines for the disinfection validation of instrumentation?

(a) Good Manufacturing Practice for Medicinal Products; Eudralex “The Rule Governing Medicinal Products in the European Union”, Volume 4. Last update: 10/10/05
(b) David E. Gronostajski, “Understanding Contamination Control for Process Validation”, A2C2 MAGAZINE, March 2003
(c) FDA “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice” (September 2004)
(d) ISO 11137:1995/Amd 1:2001 Stérilisation des dispositifs médicaux – Prescription pour la validation et le controle de routine – Stérilisation par irradiation
(e) Good Manufacturing Practice for Medicinal Products, Annex 15 “Qualification and validation” – Eudralex “The Rule Governing Medicinal Products in the European Union”, Volume 4. Last update : 10/10/05
(f) Good Manufacturing Practice for Medicinal Products, Annex 2 “Manufacture of Biological Medicinal Products for Human Use” – Eudralex “The Rule Governing Medicinal Products in the European Union”, Volume 4. Last update : 10/10/05
(g) Good Manufacturing Practice for Medicinal Products, Annex 5 “Manufacture of Immunological Veterinary Medicinal Products” – Eudralex “The Rule Governing Medicinal Products in the European Union”, Volume 4. Last update: 10/10/05
(h) Good Manufacturing Practice for Medicinal Products, Annex 1 “Manufacture of Sterile Medicinal Products” – Eudralex “The Rule Governing Medicinal Products in the European Union”, Volume 4. Last update : 10/10/05.