Good Manufacturing Practices - How you document your GMP's - GHP's and how detailed

[Red4165]

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

[JWenmeekers]

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

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

HTH

[Red4165]

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

[Al Rosen]

Originally Posted by JJFoyster

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

Could you be more specific, Pharma or Med Devs?

[Red4165]

Softdrink manufacturing

thanks

[Abdulrahman]

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

[Helmut Jilling]

Originally Posted by JJFoyster

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.

[frawat]

Originally Posted by JJFoyster

Softdrink manufacturing

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
Auditor_Checklist.doc

Model Sanitation Standard Operating Procedures.doc