new facility master validation plan

[lotus7312]

Hi,
We are constructing a new pharmarceutical facility now. I was ask to come up a master validation plan. Can someone give me some guildance or example plan? What items should I check for buildings, utilities and HVAC system?
Many thanks

 

[HEC]

Lotus7312,
It is a big question you are asking and would require volumes to reply to. Refer to the ISPE web site for more information. In summary a Validation Master Plan is teh central document that briefly summarises what it is and how you are going to validate the plant. this should include Design. Where is the plant to be built?
Feel free to contact me direct on hutton4eng@picknowl.com.au.


Mark Hutton

 

[LucayaLive]

Lotus7312

HEC is quite right, a Master Validation Plan is no small task. The Validation Plan is a roadmap that defines what you are going to to do (and by implication, not do) to validate the Plant. The scope and approach of the MVP depends on whether you are validating a Plant (in which case you will largely be writing a Qualification Plan) or whether you are Validating an entire process (in which case modules such as analytical validation, Information Systems Validation and other hangers on are included).

Whether you include HVAC's, Utilities, Buildings etc. depends entirely on the impact that theses items have on the Product or API quality. If the HVAC's are for Human Comfort, then it can be excluded. How you define whether there is an impact, which systems are to be validated and how they will be validated is basically what goes into the Validation Plan.

In my experience, if you remember what Validation is (documentary evidence that a System or Process consistently meets or performs at a predetermined specification), you are halfway home.

If you are looking for a template you will find many on the Internet. Ultimately, though, your best bet will be to draft one for yourself.

Regards,

Kevin Seymour

 

[Fenixseravgon]

I read all the messages and i think the same it is a big challenge that you face, but i think the next page can help you a lot:

http://www.picscheme.org/,

and

http://www.ivthome.com/

just keep it easy

I hope you may do it all right.

Fenixseravgon

 

[lotus7312]

Thank you all for your reply. I am initially looking for a template which I could follow. I guess there is no such template that I can follow exatly, except some guidlines.
Again, thank you for all your help.

 

[FrancisL]

Check Gamp

http://www.ispe.org/gamp/

And 21cfrpart11

http://www.21cfrpart11.com/

And
Validation Master Planning
Survival Kit NOT FREE (but why should it be?)

http://www.ivthome.com/survival kits/vmpsk.htm

 

[ecj213]

Actually I have seen and used some very good templates. They have generally been mostly focused on safety but should be easily adapted for complete facility design. You might look under something like operational readiness inspection or contact a buddy at a chemical company that does large projects.

Some of them have been directly linked to their HAZOP programs which can give you a very nice audit trail to follow as well.

I have seen several of them in the gas products industry (Air Products, Air Liquide, Praxair, BOC, etc). They have a council who's acronym I can't remember right now. Something like this may be available through that council.