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OUR MANDATE: To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food,…

Documents USP Microbiological Analysis

Page 1 of 17 1116 ENVIRONMENTS The purpose of this informational chapter is to review the various issues that relate to aseptic processing of bulk drug substances, dosage…

Documents 1-2_SterilisationValidationQualification

Sterilization - validation, qualification requirements Mrs Robyn Isaacson 1 Manufacture of sterile medicines – Sterilization - Overview Objectives – Discuss definition…