- receiving, quarantine, sampling
- release, reject, storage, labelling
- dispensing SOP
- exceptions for hazardous materials
All handling of starting materials should be in accordance with written standard procedures. Starting materials should be received, quarantined, sampled, identified, examined for compliance with established specifications, released or rejected, stored, labelled and dispensed in accordance with the written instructions.
The only significant difference from finished product manufacture arises when the material concerned is so hazardous as to prevent normal handling. Some starting materials may not be tested for compliance because of the hazards involved: examples are dimethyl sulfate and phosphorous pentachloride. This is acceptable when a batch certificate of analysis is available from the vendor and when there is a reason based on safety or other valid consideration.
Intermediate products are frequently made during active ingredient manufacturing. When this is the case, they should be tested in accordance with their specification, labelled and stored in the correct way. They are, after all, about to become starting materials for the next stage of the process. In this respect they should be treated no differently than other starting materials.
When processing is finished, each batch should be checked against the specification for all the tests. Typically this will include assay, moisture content and residues testing.