Risk management is mandatory for API manufacturers?

Dear all

ICH published Q9 for guidance on quality risk management earlier. But currently this approach is widely spreaded and some of the authorities/publications insisted in their guidelines to implement the risk management process as mandatory based on ICH Q9 Eg. PICs latest guideline for SMF preparation PE 008-4 [Effective from January 1st 2011] and ICH latest Q7 amendment. Is it mandatory to implement risk management at API manufacturing? Pls clarify any one.



Yes. Risk is for API, Biological, Formulation facilities where we manufacture multiple products.
The latest FDA guidance in line with ICHQ9 talks about idependent manufacturing facilities for Penicillins and other non penicillin antibiotics like Cephalosporines, Carbapenes etc.
The reason here is not only about a risk of cleaning and validation. It is a risk of cross contamination of products in all levels of manufacturing . The patients are sensitive to some products. In case of a cross contamination the patient safety is compromised and the patient will die or it might cause him either temporary impairment or a permenant disability in rare casses.
Hormones,Biologicals, Penicillin antibiotics,Non Penicillin antibiotics, Marcolide antibiotics, Biologicals, Allergen manufacturing facilities must have a risk assessment at all levels in manufacturing from Bulk,Storage, Formulation,Testing, Packing, Labelling.