What must be included in a "Master Validation Plan?"

This is an older thread that did not get a reply - can anyone help with this?

There's an MVP template here (you will have to register, it's free): http://www.clinivation.com/docs/protocols/ValidationMasterPlan.doc

Hope it helps.

What must be included in a "Master Validation Plan?"

Pls refer http://elsmar.com/Forums/showthread.php?t=17210

Hi
I took a look at this five page template and found it hopelessly inadequate.

The VMP has to give an overview to the regulator as to what the company does;
I.E. Personnel structures, equipment in use, cleaning, processes, plant layout, personnel flows, responsibilities and gowning regimes, product flows and containment, and how the company has integrated GMP and cGMP into all the activities it executes in producing, modifying, packaging, testing and recording regulatory controlled product, and that usually takes about 60+ pages.

Hi
I took a look at this five page template and found it hopelessly inadequate.

The VMP has to give an overview to the regulator as to what the company does;
I.E. Personnel structures, equipment in use, cleaning, processes, plant layout, personnel flows, responsibilities and gowning regimes, product flows and containment, and how the company has integrated GMP and cGMP into all the activities it executes in producing, modifying, packaging, testing and recording regulatory controlled product, and that usually takes about 60+ pages.

To say that the referenced template is "hopelessly inadequate" is hopelessly inadequate in itself since there is no real requirement, specification or regulation that says that everything you mention must be part of a MVP, it can but not necessarily have to be.

Like many other systems/documents an MVP can be as simple or as complicated as you wish to do it while still complying with regulations.