I need to prepare the IQ/OQ/PQ & DQ documents

[Pharmaentrepreneur]

Hi All,
I am new to this forum and am excited to be a part of it. We have installed our first reactor at our manufacturing site and I need to prepare the IQ/OQ/PQ & DQ documents.

Can someone give me a format for it? Its a 500 lit SS304 Reactor.


Thanks
Sam K

 

[v9991]

unless you are looking for very specific ones....try referring to the generic formats provided here...
Supplementary guidelines on good manufacturing practices: validation

Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice :- Qualification 7 Validation

Design Qualification Guidelines

How to Document Design Qualification

just in case if you have not seen this already...

 

[Ronen E]

Hi All,
I am new to this forum and am excited to be a part of it. We have installed our first reactor at our manufacturing site and I need to prepare the IQ/OQ/PQ & DQ documents.

Can someone give me a format for it? Its a 500 lit SS304 Reactor.


Thanks
Sam K

Hello Sam and welcome to the Cove

It's important to understand what is the nature of your product (a medicinal product, a medical device etc.) and under what regulatory system / standards you operate, in order to create the right documentation.

Cheers,
Ronen.