A separate set of guidelines
Good Distribution Practice for active substances is set out in the 2015 guidelines, which are distinct from the 2013 GDP guidelines covering medicinal products for human use. The structure is similar — quality system, personnel, documentation, operations, complaints and returns, outsourcing, self-inspection — but the content is adapted to materials rather than finished product.
Organisations distributing both finished medicines and active substances need to be able to show which framework governs which activity, and their procedures should make the distinction explicit rather than referring generically to “GDP”.
Registration
Importers, manufacturers and distributors of active substances are subject to a registration requirement with the competent authority, which is separate from a wholesale dealer’s licence. Registration covers the activities and the sites concerned, and changes need to be notified.
Traceability and documentation
Traceability expectations are central. Distributors should be able to trace each batch from receipt to supply, retain the documentation received with the material, and pass the necessary documentation to the recipient.
Certificates of analysis are a particular focus. The distributor should ensure the certificate accompanying supply relates to the batch supplied and originates from a source that can be established, rather than being reproduced without traceable provenance.
Repackaging and relabelling
Repackaging, relabelling and any subdivision of batches move an activity toward manufacturing and carry additional obligations. Distributors who repackage need to understand whether the activity has taken them outside distribution and into a regime requiring different authorisation.
Where relabelling is performed, the original batch identity must remain traceable and the new labelling must not obscure or contradict the information required.
Storage and transport
Materials should be stored and transported under the conditions specified by the manufacturer, with the same underlying logic as finished product: define the conditions, monitor them, and be able to demonstrate they were maintained. Contamination control and segregation carry additional weight because active substances are frequently handled in bulk.
Common questions
- Do the 2013 GDP guidelines apply to active substances?
- No. The 2013 guidelines cover medicinal products for human use. Active substances are covered by the separate 2015 guidelines on principles of GDP for active substances.
- Do we need a wholesale dealer’s licence to distribute active substances?
- A WDA(H) covers medicinal products. Active substance activities are subject to a registration requirement instead, and the two are not interchangeable.
- Does an active substance distributor need a Responsible Person?
- The named RP requirement attaches to the wholesale dealer’s licence for medicinal products. The active substance guidelines require designated responsible personnel with defined authority, which is a related but distinct expectation.