Module 2 Regulations - Lyophilization Freeze-Drying模块2法规-冷冻干燥的冷冻干燥.pptVIP

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2018-08-26 发布于湖北
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Module 2 Regulations - Lyophilization Freeze-Drying模块2法规-冷冻干燥的冷冻干燥.ppt

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Module 2 Regulations - Lyophilization Freeze-Drying模块2法规-冷冻干燥的冷冻干燥

Question 3 of 3 Quiz Question: Suppose a product has failed to advance out of freezing. i.e. The product froze correctly, but the condensers never reached set-point and thus vacuum was not initiated and primary did not start. What to do? Module 2 Summary Required Testing for a Pharmaceutical Lyophilization Product. Basic Pharmaceutical Equipment Requirements Begin thinking about event recovery. * As a handout, I should provide a Saturation Table and extensive conversion formula. As part of the exercise, we should cover how to use the conversion formula. * international ? Institute for International Research, Inc. 2006. All rights reserved. Module 2:Regulations Module 2 Purpose and Objectives Module Purpose: Content will presuppose a sterile lyophile in glass vials and will review general regulatory requirements. Module Objectives: After this module, you will be able to Identify essential testing requirements Understand what makes a machine comply with cGMP sterility and cleaning Participate in a discussion of event recovery End Testing Requirements USP 1Injections 905 Uniformity of Dosage Units 85 Bacterial Endotoxin 921 Water Determination Reconstitution time Identification Assay Elegance? Stability USP 1 Injectable Finished Product Requirements Product must pass USP sterility test There will probably be an endotoxin specification Reconstituted product must pass a visible particle inspection Reconstituted product must pass a Small Volume parenteral particulate test. Uniformity of Dosage Units Tier Testing 1: No more than 1 of the 10 dosage units lies outside the range of 75% to 125% of the label claim and none of the 10 doses is outside the range of 65% to 135% of the label claim. If 2-3 units are outside 75% to 125% of the label claim, but no unit outside 65% to 135% of the label claim, test 20 additional units. Uniformity of Dosage Units Tier Testing 2 (on 20 additional units) No more than 3 of 30 dosage units are outside the range of 75% to 125% o