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Use of OQ cleared batch for stability and clinical study use

#1
Hi everyone,

New to the forum so please forgive if this is in the wrong place.

With regards to a combination product, could anyone advise if it is acceptable to use a batch manufactured by an OQ cleared line for use of such batch in stability and clincial study use?

The product is in early development phase.

If this is not acceptable a separate PQ phase shall we developed before any attempt to use batch for aforementioned uses


2) . The assembly of the combination device will be done annually by operators until launch. A semi-automated line will be implemented around 2024/2025. So the devices supporting stability batches and clinical batches will come from a manual assembly process. This manual assembly process will be validated. The device sub-components will be designed freezed and coming from a qualified manufacturing pilot line. My question for you is key. Do we need the manual assembly process validated before the product stability batches ? And same question for clinical batches ?

Thanks a lot for your feedback. Have a nice day
 
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