ISPE Baseline Pharmaceutical Engineering Guide Series

[zsadiq]

Hello Friends,

This forum seems to be quite inactive these days. I want to ask some advice on ISPE Baseline Pharmaceutical Engineering Guide Series. Many of you must be using it. Please tell me how helpful this guide is and also share your experiences based on information used from this guideline.

Regards

 

[MedicineEng]

We use it specially the one for the utilities and the revamping of pharma facilities.
It is a good guide, but you have to be carefull in the design qualification phase to not to aim too high in relation to your needs otherwise you will have a hell of time to qualify your installation. Keep it simple and realistic.

 

[zsadiq]

What was the aim for revamping. Were you trying to go for anything like FDA Approval etc. Which part of the world are you located?

 

[quark]

Basedline guides give you general procedures and 'what not to do' kind of instructions. They are excellent resources for a starter but just a reference for experienced people. By the time I referred them first time, I had about 8 years experience and I opined I knew what they are saying, related to my field, more or less.

 

[MedicineEng]

we are FDA approved since 1988/89. The revamping was to upgrade somea reas. We consulted the ISPE and ICH to be sure that with the revamping we were not raising new problems that later on needed to be adressed.

We are located in South China.