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Ingredients used in medicines – guidance for importers and distributors
SUMMARY OF:
Guidelines on principles of Good Distribution Practice of active substances used in medicines
SUMMARY
WHAT DO THE GUIDELINES DO?
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These European Commission guidelines seek to ensure that ingredients used in medicines intended for human use are carefully handled and stored. This is to prevent them being damaged or losing their beneficial properties.
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They are directed at importers and distributors of these medicinal ingredients.
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They constitute stand-alone guidance on good distribution practice.
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KEY POINTS
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Distributors must develop and maintain a quality system covering responsibilities, processes and risk management.
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They must ensure the system is adequately resourced with competent personnel, and suitable premises, equipment and facilities.
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Each distribution centre must have one person responsible for ensuring the quality system is implemented and maintained.
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Documentation, in paper or electronic form, covering all instructions, contracts, records and data, must be readily available and retrievable.
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Records must be kept each time an operation is performed in a way that all significant activities and events are traceable. They should be retained for at least 1 year after the expiry date of the batch to which they apply.
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Premises where medicinal ingredients are stored must be secure against theft, provide controlled temperature and humidity and designed to prevent contamination or any mix up.
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Ingredients which are returned should be identified and quarantined while an investigation takes place.
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All complaints, received orally or in writing, must be recorded and investigated according to a written procedure.
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Complaint records must include detailed information ranging from the name and address of the complainant to any follow-up action taken.
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ACT
Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (OJ C 95, 21.3.2015, pp. 1–9)
last update 03.12.2015