From ISO 13485 to EU Pharma GMP

K

kabemueller

#1
Hey Folks,
I am QMR of a Germany based medical device manufacturer, and we are in the process of adding a GMP facility for vet medicinal products to our existing MD manufacturing site.
Right now we are digging our way through the EU GMP regulations, and one of the first questions we have is this:

As we already have the procedures and documents in place according to MDD and German regulations, we are looking for a way to keep the total document volume as small as possible, for obvious reasons like less document control work, a lower risk of people mixing up similar forms, and more.

Our idea is to amend as many procedure descriptions, SOPs and forms as possible so that they are applicable to both systems (as far as I can tell today this will be general QM, complaints, CAPA, document control, purchasing, maintenance and repair of equipment, general storage and shipping instructions, personnel training and qualification). Only the docs that are very different, e.g. those for production, special QC procedures or management of records will be separate.
I am not sure yet about the qualification and validation instructions, though.

Will this be acceptable to pass the GMP inspection? Or will we have to go the long way? What is your experience?

Thank you for you replies! :)

Karen
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hey Folks,
I am QMR of a Germany based medical device manufacturer, and we are in the process of adding a GMP facility for vet medicinal products to our existing MD manufacturing site.
Right now we are digging our way through the EU GMP regulations, and one of the first questions we have is this:

As we already have the procedures and documents in place according to MDD and German regulations, we are looking for a way to keep the total document volume as small as possible, for obvious reasons like less document control work, a lower risk of people mixing up similar forms, and more.

Our idea is to amend as many procedure descriptions, SOPs and forms as possible so that they are applicable to both systems (as far as I can tell today this will be general QM, complaints, CAPA, document control, purchasing, maintenance and repair of equipment, general storage and shipping instructions, personnel training and qualification). Only the docs that are very different, e.g. those for production, special QC procedures or management of records will be separate.
I am not sure yet about the qualification and validation instructions, though.

Will this be acceptable to pass the GMP inspection? Or will we have to go the long way? What is your experience?

Thank you for you replies! :)

Karen
Hi Karen,

I once worked for a pharma company, some of whose products were classified as medical devices (sort of pastes with no pharmacological effect). Based on that experience I see no reason why you couldn't succeed in such a plan - enhancing an ISO 13485 compliant system to meet applicable GMP regulation. As long as the resultant system will meet all applicable GMP requirements, it shouldn't concern any auditors either that it's also maintained as ISO 13485 compliant, or that the ISO 13485 compliance predated the GMP enhancement.

Bear in mind though that you could easily end up with an over-extensive / cumbersome system if you're not careful. You're goal is to find a way to accomplish 2+2=3 (2+2=4 is quite easy, and if you're not careful you may end up with 2+2=5 in terms of paperwork, time spent etc.).

Good luck,
Ronen.
 
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