5.4 Inventory Control Program

This page will address various regulatory issues related to this section of the GMP Institute framework.  Click below to view the issues that are relevant to you.

How long may a firm store in- process/intermediate powder blends and triturations, sustained-release pellets/beads, and tablet cores, absent separate stability studies, before using them in the finished drug products?

How long may a firm store in- process/intermediate powder blends and triturations, sustained-release pellets/beads, and tablet cores, absent separate stability studies, before using them in the finished drug products?

Reference: 
21 CFR 211.110 (Sampling and testing of in-process materials and drug products); and 
211.111 (Time limitations on production)

For such intermediate/in-process materials that are known to be chemically and physically stable, a holding period of up to approximately 30 days (under appropriate storage conditions), before use in manufacturing a finished drug product, is generally acceptable without conducting stability studies to verify the holding periods.

However, for unstable materials, or for such materials held for longer than approximately 30 days before use in manufacturing a finished drug product, stability studies should be conducted according to an approved stability protocol to verify the holding periods. The stability studies should include evaluations of the in- process/intermediate materials up to the time of their use in manufacturing a finished drug product, and should include long-term monitoring of finished product batches manufactured with the in-process/intermediate materials.

In the latter case, until appropriate stability data is generated, the expiration date assigned to finished product batches should be calculated based on the date of manufacture/release of the in-process/intermediate material, rather than on that of the finished product. 

Contact for Further Info: Barry Rothman, HFD- 325, 301-594-0098, e-mail: rothmanb@cder.fda.gov