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www.gmpua.comAPPENDIX A PROCEDURE The felloving procedures and eri:erla are used for in I c la I qualification and r equaliflcacion Of analysts in the laboratory, and to test nev lots
PFR Validation guide - gmpua.com
www.gmpua.comValidation Guide Validation Guide for Pall® Emflon® PFR Filter Cartridges USTR 2114(2)
Cleanroom For Sterile Manufacturing Facilities - gmpua.com
www.gmpua.comWHO TRS No. 823 Annex 1, 1992 (4) General Low values for contaminants are reliable only when a large number of air samples are taken. ¡The guidance given for the maximum permitted number of particles corresponds approximately to the United States Federal Standard 209 E (1992) as
Autoclaves Qualification & Validation - gmpua.com
www.gmpua.com2 of 39 Autoclaves: Qualification & Validation Holger Fabritz - Expertentreff 14. September 2007 in Baden Contents • Types of autoclaves • Regulatory Aspects • GMP Risk Analysis • URS / FDS • Design Qualification • Installation Qualification / Operational Qualification • Performance Qualification / Process Validation • Responsibilities • Summary
World Health Organization - gmpua.com
www.gmpua.comWorld Health Organization Supplementary Guidelines on Good Manufacturing Practices for Heating,Ventilation and Air conditioning (HVAC) Systems for Non-sterile Dosage Forms