dear all,
where could I get the document related to GMP for hormone or hormone-like drug products, cytostatic drug products?
thanks in advance.
regards,
siswanto
GMP’s are GMP’s no matter what the product. I am not sure what you are asking for. With these type products you have other issues such as contamination and containment to deal with. HVAC Controls, Room Classifications, etc need to be designed for the usage. Please see ISPE Good Practice Guide HVAC, and maybe the Oral Solid Dosage one as well.
Dear all
I would like to recommend WHO guideline on “GUIDELINE TO THE INSPECTION OF HORMONE PRODUCT MANUFACTURING FACILITIES”.
Kiatpornsiri