ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 7.3: Test at least identity on each incoming batch, rely on supplier certificates only after supplier qualification with periodic full testing, justify exemptions and sample representatively

What does 7.3 require?

At least one identity test should be done on each batch of material, except for the categories below. The supplier's certificate of analysis may stand in for other tests if the manufacturer has a supplier evaluation system. Supplier approval should give adequate evidence (such as quality history) that the supplier consistently meets specification; full analysis should be done on at least three batches before in-house testing is reduced, and at suitable intervals thereafter compared with the certificates, whose reliability should be checked regularly. Process aids, hazardous or very toxic raw materials, other special materials and materials moved to another unit within the company need not be tested if a certificate of conformity is obtained, with container and label checks and batch recording supporting identity, and the reason for not testing documented. Samples should represent the batch, with a sampling plan setting containers, location in the container and amount, based on criticality, variability, supplier history and analysis needs. Sampling should be done at defined locations by procedures preventing contamination, and sampled containers opened carefully, reclosed and marked.