The draft guidelines - which were issued on February 6 - set out how firms involved in transporting active pharmaceutical ingredients (APIs) within the European Union (EU) should monitor quality and supply chain integrity.
API distributors will have to set ‘properly’ resourced quality management and risk identification procedures that take an organization’s size and the complexity of its activities into account and as appoint key personnel at each distribution point, which both have cost implications.
They will also need to be registered under the Falsified Medicines directive , make all documentation available to authorities on request and ensure that all warehousing and distribution warehouses are robust enough to protect shipments, which again is likely to increase costs.
Distributors will also be required to transfer all regulatory and quality documentation from the API producer to the customer, including a copy of the original certificate of analysis (CoA) and the batch number.
Whether they will also be responsible for passing on ‘written confirmation’ of quality documents that manufacturers outside the EU will need send with any APIs shipped to Europe from July is unclear.
But what is clear is that distributors will need to keep accurate records of API suppliers as – under the proposals – regulators can ask for this information which - again - means databases will need to be maintained.
Returns and complaints
The proposals also set out distributors’ role in recalls and customer complaints. API shipments sent back by customers must be identified, quarantined and – if there are doubts regarding quality – should be destroyed. Distributors can sell unopened stock that is returned only if it is in good condition.
All complaints – either written or oral – will need to be recorded and details retained and made available to European member states on whose territory the APIs were distributed.
The draft guideline also states that distributors will also be required to review complaints with the manufacturer to determine if further action - such as notifying other customers or regulators – is needed, however it does not specifically define what would trigger such action.
The draft good distribution practices (GDP) proposals – which do not apply to re-packagers or firms that divide up API batches as these activities are classed as manufacturing and covered by Good manufacturing practices (GMP) guidelines – are open for public comment until April 30.