Process Validation Protocol template sample - GMPSOP
(Reference: SOP _____) Page 18 of 24 Step Study to Support Purpose Monitoring/Analysis Requirement For Information Only Acceptance Criteria 7, 22 Preparation of Tartaric acid solution and addition to Glatt Mixing time Solution appearance – no signs of undissolved material Solution temperature - 70°C 8, 23 Addition of Purified Water
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