A general question that seem to arise more frequently these days – manufacturing hormones in a multi-use facility. I am not aware of any actual regulatory prohibition that specifically says a hormone product cannot be made in the same facility as a non-hormone product. Am I incorrect? I realize that bringing a hormone product into a facility where non-hormones are being made will raise eyebrows. I'm aware of (and have audited) facilities that are dedicated to hormone products (e.g. birth control pills). But occasionally I have been approached by firms who make a host of non-hormone products and wish to introduce a hormone product into their product line. In my opinion, the introduction of any product – hormone or non-hormone – into any manufacturing environment should trigger the same scientific evaluation regarding the toxicity, potency, safe handling, ability to clean, equipment issues, room issues, HVAC issues, etc. Certainly there can be non-hormone products that may introduce more significant issues regarding their toxicity, potency, safety, etc. than some hormone products. One does need to recognize that hormones are on the more potent end of the spectrum (some more than others) and cross contamination into any other products is a concern. But with the proper risk analysis, concerns can be minimized through the use of dedicated areas and equipment, closed manufacturing operations, etc. Just as with any drug, there are different risks depending on the drug (e.g. handling powders vs liquids) and one must consider process controls. But unlike the case with betalactams and their significant serious allergenic potential to a large part of the population such that operations – even entire buildings – are kept totally separate today, I have not seen that with hormones across the board. But I have heard folks make general wide ranging proclamations that hormones are not allowed in a non-hormone facility or on equipment used for non-hormone production. However when I ask to see where the actual regs are that say that, I get silence. I'm open for input. Chris
Christopher Smith, CQE, RAC
President, Coastal Pharmaceutical Consultants, Inc. ®
7950 Old River Road, Burgaw, NC 28425 USA
+1-910-789-1232 (mobile)
chrissmith@coastalpharmaconsultants.com