I would like to impliment QBD concept in existing API manufacturing process. I read ICH Q11 & FDA QBD document. Outline is available in the document. But I need an example & protocol to impliment. Pl guide me or send document copy at nil2upadhyay@gmail.com
It depends on what you are manufacturing. Every protocol is unique (and confidential)!
Dear Nil,
actually QbD is not a protocol. In my point of view, it is a concept which says that you have to consider quality from designing a manufacturing site, purchasing the equipment, utilities and… to send a product to the market.
may be you can have a protocol for this aim, but bear in mind that the most important thing is acting according to that.
It can be started from wiring the URS by considering GxP requirements, designing your manufacturing site and water system and HVAC system and …accoring to GMP, then performing DQ …and so on.
Good luck