Hi all

Does anyone have any examples/samples of how they document their GMP's - GHP's and how detailed do you go with your documentation etc

JJ - I can't come up with 'real' examples, GMP is not in my book anymore.

I found in my years old documentation a link:

WHO Guide to GMP Requirements.pdf (http://elsmar.com/pdf_files/WHO Guide to GMP Requirements.pdf)

maybe it's a start, or it can give you some ideas.

HTH

Hi and many thanks for your assistance. It will take me a bit to read through the 100pages, I am sure that it will head me in the right direction though. Many thanks once again.
Cheers
JJ:thanx:

Hi all

Does anyone have any examples/samples of how they document their GMP's - GHP's and how detailed do you go with your documentation etcCould you be more specific, Pharma or Med Devs?

Softdrink manufacturing:tg:

thanks

Hi All
Does any one have GMP for pharmacuital industries.
Regards
ARA

Hi all

Does anyone have any examples/samples of how they document their GMP's - GHP's and how detailed do you go with your documentation etc


I have one client who is under GMP and ISO 9001 requirements. Their GMP procedures, etc. are the same for ISO and GMP. They have one combined system. The only difference is they feel GMP requires a few more proceders than ISO-9001:2000 would, but it is a combined system.

Softdrink manufacturing:tg:

thanks
Hi JJ,

I would recommend first to outline all your GMP or PRP programs (see for example the NFPA-SAFE checklist). Then it all depends on the objectives or requirements you want or need to meet.

You can have policy statements or guidelines, procedures, quality plans or schedules, work instructions, etc. Also reports are important (analyzing & summarizing data, actions taken, etc.).

I personnally think that the SSOP structure is very useful for specific subjects:

- purpose of SSOP
- control measures
- standards or details to meet
- monitoring
- corrective action
- verification procedures
- records

regards,
Francis
4699

4700

hI Guys,
I'd been reading lots of articles about GMP, and how are we going to relate this on our current process. Our company is engaged in food industry. In our case, we conduct a line audit on our manufacturing area plus on the store that we cater.
Just like in ISO9001:2000, these practices were documented based on what the requirements is told us what to do. So that we could track what has happened during the earler times and what could be the improvement are we going to make for us to lessen product rejections and damages.
Hope this helps.

Btw, thank you for the attached auditor's checklist and Model Sanitation SOP . Its great.
Thank you very much.
Best regards,
Raffy