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The evaluation of the risk to quality is based on scientific knowledge
The definitions and interpretations of terms in section 201 of the Federal Food
follow and maintain written procedures for laboratory operations
Regular periodic or rolling quality reviews of all authorised medicinal products should be conducted with the objective of verifying the consistency of the existing process
to ensure uniformity in every finished batch and that it meets its specification
1.6 - Good Distribution Practice GDP employees The evaluation of the riskGDP covers all activities consisting of procuring, holding, supplying or exporting medicinal products or active ingredients, apart from supplying medicinal products to the public. In Europe, any person acting as a wholesale distributor has to hold a wholesale distribution authorisation