Should immunosupperrasants like Leflunomide be manufactured in a dedicated area

Dear Drs.

Should immunosupperrasants like Leflunomide be manufactured in a dedicated area or is cleaning validation enough? Please, whoever answers add reference.

If you have proper HVAC design and air containment with out mixing of contaminants by way of air handling or material flows it is enough. The depth of such design and prevention of material mix-up from storing, sampling , Testing, Manufacturing, Packing and Dispatch must be properly analysed,tracked and regulated.

This comes with an investment in a multiproduct manufacturing facility. If you do not have that finance better go for an independent facility.

I do not think there are no shortcuts while dealing with cleaning validation of such sensitive products.

Dear Durga,

Thanks alot for your reply! I need to forward your reply to a regulatory authority but with international references. Could you help me in this?

Dear Sherin,
The whole concept lies in Identification, Assessment, Analyzing, Calculating & Reduction of Risks associated.
This is available as Risk Guidance : ICH Q9, QRM-WHO, Annex-15 (Validation and Change control)
You need to consider Risks associated with Mix-ups, Cross contamination, Material transfers, Material flows, Man power movement,Utility considerations and Process considerations.

To do this you need to categorize first your scope into 3 categories as per available GMP guidelines in your country:
-High risk Impact systems
-Medium Risk Impact systems
-Low risk impact systems

You need to show there is reliability in Process, Machines, Utilities, Quality testing, Training by assessing all risks by calculating the Risk Priority Numbers and then making a proper Design qualification and verification process by considering all Corrective and Preventive actions and then applying the fundamentals of all Change controls and then their risk impacts with systems and sub-systems.

At the end of the documentation you need to show that there is a process improvement with all reliable controls in-place to produce quality product as described in the initial Quality attributes of your product.

Quality Risk Management system is primarily designed to improve the process manufacturing and its quality. This is also widely used during Design Verifications.

Dear Durga,

Thanks alot. You are always a great help. Happy new year!

Yes Durga, you always provide members here with great knowledge, thanks so much!