ISO vs. GMP

I work as a validation assistant in a small danish company. In my oppinion we we tend to do things the wrong way round. And I could really use some help or links with some answers. Here is my problem:
My company is a machine manufacturer - among other things we produce small-scale filling machines (filling, plugging and capping) for pharmaceutical industry (however we often sell to all the “big” names within this area).
Some years ago the company was ISO 9001 certified.
At the moment we are working on a new type of pump control module; the development of this module follows GAMP5. However GAMP5 states issues about Good Document/Test Practice and GMP.
My problem now is that my quality manager seems to think that these issues should be handled under ISO and written in the ISO quality manual.
I think that if we want to comply with GMP it is not just something you write as a ISO standard. I think we should describe clearly which kind of documents we define as quality doc’s and these must comply with GMP.
I have searched the internet continuously and all I can find is links and articles about companys who allready comply with GMP and want to be ISO certified.
Do any of you have any solutions to this ???
kind regards
Dorthe in Denmark

What I understand from your post is that you are asking about whether we can club ISO and GMP documentation together. If I am right in the interpretation, there is no logic as to why we shouldn’t do it. The important thing to understand is that ISO 9001 is a quality management programme. What they look into is how you are managing the processess for obtaining and continuously improving the quality. You will not get any clues about what is the quality that you have to maintain in your process. On the other hand cGMP tells you precisely (and sometimes indirectly) what you have to maintain to get a good quality. Many times, ISO may not ask for phenominal change in your quality aspects but GMP does.

As long as you follow the guidelines and codes, it shouldn’t matter under what heading you are preparing your documents.

My problem now is that my quality manager seems to think that these issues should be handled under ISO and written in the ISO quality manual.
I think that if we want to comply with GMP it is not just something you write as a ISO standard. I think we should describe clearly which kind of documents we define as quality doc’s and these must comply with GMP.
I have searched the internet continuously and all I can find is links and articles about companys who allready comply with GMP and want to be ISO certified.
Do any of you have any solutions to this ???
kind regards
Dorthe in Denmark[/quote]

I do not think that this is a bigger problem. It is not a big issue to keep the documents under GMP or ISO. It is not a big issue if those documents are handled under ISO manual. The first thing that you have to document is what you have done. This is the main principle of documentation and both ISO and GMP agrees in this regard. Neither GMP, nor ISO ask why you have keep this document under ISO or GMP. Both are for the company and you should not hang around saying this should fall under GMp and this falls under ISO. What I think is you should agree with your manager.

Good day

You as the manufacturer really have no connection with GMP in as much as you are not required to validate your equipment. However if you have followed a structured method of quality control and assurance during design and manufacture, you will have produced all the engineering drawings, documentation and certification, that the end user will require to complete the validation task.

You should suggest that you carryout a Gap Analysis to reassure everyone that this is the case, since the absence of certain certification could render you equipment as ‘not validatable’ .

Regards
Alex Kennedy