Topic: When mfging both steroid and non-steroid products, do we need a dedicated/separate line or a common line?14 May 2014 Last edited: 14 May 2014 At 3:46pm
Tye Spillum, PMP Community Member 1 Post
Re: When mfging both steroid and non-steroid products, do we need a dedicated/separate line or a common line?14 May 2014 at 3:50pm
There are no FDA/EMA/WHO guidelines prohibiting the manufacture of steroid & non-steroid products utilizing the same manufacturing facility, line, or equipment. The only products prohibited from manufacture within the same facility are penicillin products by 21 CFR 211.42(d).
WHO document, “Quality assurance of pharmaceuticals” 2nd edition dated 2006 provides some additional guidelines & information as well as EU Guidelines to GMP Annex 1 for Sterile Medicinal Products.
Please feel free to reach out to me as my consulting service offerings address / advise on these & several similar issues.