Module 3 2019

How to define/specify the desired quality?

• Requirements are defined during the development phase and documented in specifications • The requirements may change during the lifecycle of the packaging material • E.g. due to new requirements from the pharmacopeia, from laws, due to experience in the market (complaints) or due to change of the pharmaceutical product or the manufacturing process • A regular review of the specification, especially against “the state of the science and technology”, is recommended

The Organisation for Professionals in Regulatory Affairs

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