Heloo All,
Can anyone tell me something about VMP, my doubts are
1.We are constructing a new site for manufacturing of solid dosage form. At what stage we should write VMP?
2.Does VMP should mention the timelines of qualification once the plant is fully ready and all equipments are qualified? Is it necessory to revise VMP everytime new equipment is added?
3.Is it mandatory to issue a controlled copy to all departments because it is lot of work to photocopy a VMP along with plant layouts.
4.VMP is validation strategy, is necessary to include plant layout in VMP?
VMP is a living document just as others. No need to put timeline in VMP, just refer to the document that has that information.
It should be controlled.
I would not put drawings in, just refer to them. That way when drawings change you do not have to update VMP. Summerize the facility, systems and equipment. High level overview.
Hello All,
Can anyone tell me something about VMP, my doubts are
1.We are constructing a new site for manufacturing of solid dosage form. At what stage we should write VMP?
The sooner the better. I wrote a VMP for a plant in Singapore that was to be built on reclaimed ground, but it was still under the water when I wrote the VMP.
2.Does VMP should mention the timelines of qualification once the plant is fully ready and all equipments are qualified? Is it necessary to revise VMP every time new equipment is added?
Times lines and equipment lists are required and should all form appendices to you VMP, making them easy to edit or change.
3.Is it mandatory to issue a controlled copy to all departments because it is lot of work to photocopy a VMP along with plant layouts.
You produce a limited number (1 to 3) of original fully signed off VMP’s. During construction and all the commissioning activities you may use uncontrolled copies. Issued but stamped all over ‘boldly’ that they are uncontrolled copies. This gives people access to the procedure and responsibilities that are being authorised by the approval of the VMP.
4.VMP is validation strategy, is necessary to include plant layout in VMP?
It is required that a person reading your VMP will gain an overall picture of your plant, facilities, utilities, processes and knowledge of how all the applicable GMP requirements have been integrated into them. Validation responsibilities and methodologies must be fully detailed. Most definitely drawings of layout, product acces & egress, personnel access & egress, HVAC regime, Gowning area. In fact everything you need to get this overall picture.
Go to http://www.validation-online.net/validation-master-plan.html
for further free details.
