Tag Archives: ich

Chamber Mapping & Qualification

chamber mapping & qualification

Introduction In Chamber Mapping and Qualification we describe how mapping is used in the Pharmaceutical and Medical Devices Industries and the mapping service DACTEC provides. Each market’s regulatory authority e.g., the FDA (Food & Drug Administration) in America, the HPRA (Health Products Regulatory Authority) in Ireland mandates the validation of environmental conditions that can affect […]

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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