Guidlines on how to write IQ,OQ,PQ and process validation protocols

Hi Mediana,

Thanks for posting the useful information on how to write validation protocols…

Chris

Can you send it to me by e-mail because i don’t download this attachment?

My Emai:wzhong2@163.com

Thank you!

Attached Part 1 of WHO for ur perusal


WHO GMP PART 1.pdf (346.8 KB)

I do not know why people are searching for readymade protocols. Protocols must be prepared by understanding the process, by knowing the quality requirements and knowing your organization’s requirement.

My suggestion is first understand the requirement that may be quality requirement, productivity requirement or any other requirement. Then identify the variables that affect the quality of the products, then make an action plan for controlling the variables, then plan for testing and documenting the test results. Write the objectives, scopes, responsibilites approval and others as per your SOPs.

This is a simple example of preparing validation protocol.

Thanks for Sharing guideline

[quote=me_av@hotmail.com]dear colleagues

Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you.

best regards
Mediana[/quote]

Thanks for sharing
Ravindra Upare:)

Thanx,
just what I needed to find a good template
regards Conversano

Thanks a lot,
Regards,

[quote=daprawan]I do not know why people are searching for readymade protocols. Protocols must be prepared by understanding the process, by knowing the quality requirements and knowing your organization’s requirement.
My suggestion is first understand the requirement that may be quality requirement, productivity requirement or any other requirement. Then identify the variables that affect the quality of the products, then make an action plan for controlling the variables, then plan for testing and documenting the test results. Write the objectives, scopes, responsibilites approval and others as per your SOPs.
This is a simple example of preparing validation protocol.[/quote]

I agree 100 %!!!Excellent post!! I think so, like daprawan. Most of people want to write protocols even they never was in the production area! The most important is to protect process, not write protocol just like that, just to be present.

rgds,

cubica:confused:

Thanks a lot for the protocol
thanks,
SRI