Suppliers, receipt and raw materials

Procedure

1. Qualify suppliers for identity, quality, traceability and recall capability. Define an appropriate pharmacopoeial or other justified specification.
2. At receipt check the name, salt/hydrate form, lot, integrity, quantity, expiry and transport conditions.
3. Match the CoA and SDS to the exact lot/material. Assess identity, assay and critical impurities; the document title alone is insufficient.
4. Quarantine until the required review is complete. Record acceptance or rejection by an authorised person.
5. Label opening date, conditions and any justified in-use period. Segregate allergens and incompatible materials.
6. Maintain inventory and lot movements using earliest-expiry priority. Every substitution or supplier change enters change control.

Edition-specific detail

F-017 records exact chemical form, compendial grade, supplier, lot, CoA, SDS, transport conditions and quarantine/release decision. Potency or water corrections use the actual CoA and formulation instructions. A retest date is not automatically an expiry date.

Related forms

F-017, F-007