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Informing customers of a process change

Q: I am making a process change in the manufacture of an excipient. Do I have to inform my pharmaceutical customers?

A: Irwin Silverstein answers:

The FDA expects that the excipient manufacturer will notify its customers of all significant changes. If you have a Drug Master File for the excipient with the FDA, you will also need to notify them.

Process improvements and cost reductions are essential to remaining competitive in the chemical industry. It is very difficult to make improvements to a chemical process also used to produce excipient grade ingredients without also applying those changes to the excipient process.

To address this issue, IPEC developed the Significant Change Guide for Bulk Pharmaceutical Excipients. It establishes criteria that should be evaluated in order to determine whether the process change might have an impact on the excipient as used by the pharmaceutical customer. The guide attempts to break down typical changes into three levels, rising from Level 1, where a change is considered insignificant, to Level 3, where the change has such a potential for impacting the excipient performance in the drug formulation that the pharmaceutical customer should receive advanced notification that a change is to be made.