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Extension to scope for new process

BSI scope GMP process extension

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telizabeth

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Posted 07 May 2021 - 04:11 PM

Hi all, we are a medical cannabis company manufacturing a variety of products under a GMP certificate from BSI. We intentionally wrote a broad scope, which is displayed on our certificate that states: "Manufacture of cannabis products intended for inhalation, smoking, topical and oral usage" We kept it broad to allow us to produce several different types of SKUs without needing an extension to scope and additional audit every time we wanted to make a new product. We recently built a kitchen to start producing edibles and I figured the product, equipment, process was different enough to warrant another audit to extend our scope so now the current scope is:  "Manufacture of cannabis products intended for inhalation, smoking, topical, oral and edible usage" The scope is now broad enough it seems just about anything we could want to make would likely be covered by it. My auditor disagrees and says all new processes require an inspection and extension to scope. Do we really have to schedule an audit/inspection every time we want to make a new product? This seems like overkill. When is an extension to scope required? How 'different' does the process or product have to be to necessitate another inspection? Who gets the final say in this as it seems like it could be very subjective. Thanks for any insight! 


Edited by Jacob Timperley, 08 May 2021 - 11:11 AM.


Fred73

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Posted 07 May 2021 - 04:54 PM

HI Elizabeth

what you need to consider is if there is any change in the risk in the new process?

I believe any time a new product is developed or new line is added a new analysis of the risk involved in the process need to be completed, that's why BSI mention you need to extend your scope any time that happen. 

It is very common in companies that are rapidly growing, a new product or new line is added then you need to get all the paperwork together for that process IF is different of what your scope is.

Hope this help.

Good luck.

 

pd: following up in the description of the scope you mentioned, adding "edibles" could add new risks of product contamination to your process, that's why a new analysis/audit is needed.



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