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Tag Archives: 21 cfr part 11

Stability Testing – An Overview

What is Qualification in the Pharmaceutical Industry?

Introduction In Stability Testing – An Overview we look at stability testing requirements – chamber choice , validations requirements, IQOQPQ & IPV considerations. To prove the shelf life of a drug in a certain market, the manufacturer must store it at a relevant temperature and humidity for a specified time. This is done in a […]

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