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1.6 - Good Distribution Practice GDP employeesGDP 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
The definitions and interpretations of terms in section 201 of the Federal Food
manufacturing process
If the result of any test or examination fails to meet the established specification or trend
The evaluation of the risk to quality is based on scientific knowledge
follow and maintain written procedures for laboratory operations
The measures to prevent cross-contamination should be commensurate with the risks using Quality Risk Management principles to assess and control the risks
comply with applicable Federal
Quality risk management is a systematic process for the assessment
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
repeatability
3 years after distribution of the batch
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