Pharmaceuticals/dedicated and separate facility for hormone mfg?
Product is a generic version of GSK's Seretide (Active ingredient: fluticasone propionate). If we will sell the product to US market, the facility should be separated from any other non-hormone facility? If not what kinds of technical measures should be considered (e.g., 100% exhaust air handling system, etc.)
ANSWER: Fluticasone is a corticosteroid, not a sex hormone, and as such the requirements for separation of facilities is less stringent. You requirements will need to include:
a. separate air handling facilities, and filtration of exhaust air;
b. the fluticasone facility to be at a negative pressure differential to the remainder of the facility;
c. separate material storage and movement;
d. separate people gowning and movement
I hope this helps.
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QUESTION: Dear Mr. Anisfeld,
Thank you for your kind and prompt response. It really helps. In my humble opinion it's more practical to use a separate building for cortisteroid mfg rather than building in builidng concept adhering to the above requirements.
One more subsequent question. I can't find any US regulations regarding that sex hormones should be separated. In my search US FDA'S CGPM 7356.002 (for drug inspection) and 7356.002F (for API inspection) specifies some wording for hormone facilities. 7356.002F mentions that dedicated areas or containment controls for highly sensitizing materials (e.g., penicillin, beta-lactams, steroids, hormones, and cytotoxics). 7356.002 is less explicitly mentioning about hormones facilities. Could you please let me know which US regulations should be referenced for sex hormones facilities.
All the best.
Check out FDA's Compliance Manual at:
as well as associated WHO guidelines to which FDA also adheres.
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QUESTION: After receiving your 2nd answer I sent you my additional question but no response. Maybe some problem on this website? Anyway here is my 3rd question.
You might have some confusions. The link you posted is CPGM 7356.002F and I have this one as indicated in my 2nd question. My point is which US regulation(s) requires the separate facilities for sex hormones manufacturing. I've searched all CFR Title 21 but couldn't find any paragraphs for provisions of sex hormone facilities. This is why I'm asking you again.
I repeat my recommendation. Go to FDA's compliance policy guide CPG 7356.002 at:
and you will find "hormone" mentioned under FACILITY AND EQUIPMENT SYSTEMS.
Good Luck, Michael Anisfeld
Oh, and you are correct, I never did receive your original 3rd message.