European Regulatory Guidelines Controlled or Ambient Temperatures, Stability Data and Compliance
There is more regulatory interest in ambient products and growing opportunities for solution providers to enter this market. In this presentation Ian Holloway, Manager, Defective Medicines Report Centre, Medicines and Healthcare Products Regulatory Agency (MHRA), discusses the expectations and documenting for ambient or CRT products, regulatory expectations for qualification or validation and stability studies versus shipping studies.
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Presented at Pharma IQ's 8th Cold Chain Management and Temperature Control Summit in February 2010.