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Validation of Aseptic Processing (PI 007-3) Sept 2007
Short Title:PIC/S PI 007-3
Internet:http://www.picscheme.org/publis/recommandations/PI-3Recommendation 4520144nAsepticProcesses.pdf
Origin/Publisher:Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Content:Detailed recommendations on the validation of aseptic processes, relating to different drug formulations including statistic limits. The document refers to ISO 13408-1.
Document Type:PIC/S Recommendation