Can anyone in pharmaceutical development help me with some questions ?
1) When developing in R&D a STERILE topical form (ointment, cream, gel) what should be the requirements for the cleanliness level and sterility ? Do you have to use a glovebox, or it's enough to use a laminar flow hood ?
2) Is it necessary to follow the GMP guidelines, and have clean room, or, since it's R&D, it's not necessary.
3) Sterility of the topical product must be proven on lab scale, or validated? It is self understood that on manufacturing scale, for commercial production, sterility is mandatory, and the validation batches have to be sterile, but are there any regulations in this sense for labs R&D?
#pharma #sterility #topical #cream #ointment
From my point of you it is a matter of your purpose.
Are you in galenic development or do you need the product for clinical testing?
If it concerns the galenic development, the focus is set on the technological aspect of the product. The sterility is not that important in this step. But it should be assured that sterility could be achieved.
However, if you want to test the product on human being or animals it must be sterile. We have used a validated laminar flow box for theses purposes. Furthermore, GMP guidelines have to obeyed in this case anyhow.
see also: https://www.gmp-compliance.org/gmp-news/does-gmp-apply-to-development.
You also should check if GLP guidelines may apply:
https://www.oecd.org/chemicalsafety/testing/overview-of-good-laboratory-practice.htm
Bernd Soyke My situation is like this. I work in a company that wants to devleop and manufacture generic drugs. On project involves a generic sterile drug. As we do, the first phase is to develop it in the laboratory, then scale up to production size, and lastly validate for production. I know that the validation batches used for human testing and for commercial purposes must be sterile, but my question was about the laboratory scale research. Laboratory testing is neither galenic (which I suppose means compounding) nor for clinical investigation.
From my point，If it concerns the galenic development,the first step is to examine yourformulas，excipients and pharmaceutical packaging materials solutions used ultimately meet the sterile requirements during the stability period. And then , without compromising the sterile plan，the other R&D behavior no need to worry about sterility issues
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