can we prepare beta and non beta APIs in one premise
The following is quoted from FDA guidance document which is present in the following link:
"With respect to penicillin, § 211.42(d) requires that “[o]perations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use.” However, FDA has clarified that separate buildings may not be necessary, provided that the section of the manufacturing facility dedicated to manufacturing penicillin is isolated (i.e., completely and comprehensively separated) from the areas of the facility in which non-penicillin products are manufactured.2 Under § 211.46(d), manufacturers must completely separate air handling systems for penicillin from those used for other drugs for human use. Additionally, § 211.176 requires manufacturers to test non-penicillin drug products for penicillin where the possibility of exposure to cross-contamination exists, and prohibits manufacturers from marketing such products if detectable levels of penicillin are found.3
Although FDA has not issued CGMP regulations specific to APIs, the Agency has provided
guidance to API manufacturers in the guidance for industry, ICH4 Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH Q7 guidance).5 Because some APIs are sensitizing compounds that may cause anaphylactic shock, preventing crosscontamination in APIs is as important as preventing cross-contamination in finished products.
The ICH Q7 guidance recommends using dedicated production areas, which can include
facilities, air handling equipment and processing equipment, in the production of highly
sensitizing materials, such as penicillins and cephalosporins.6"