Validation Plan Requirements when moving to a new Plant - Medical Device Industry

[lisawxf80]

Hi,

I was hired to improve the system. There is no proper job done in the current. Especially validation. And many other areas.

Since they are moving to new plant with new facility, they could like to take the chance to get everything in place. Which means everything have to start fresh.

Hope this clear your doubts.

Thanks & Regards,

Lisa

 

[alex.Kennedy]

Hi Lisa

You are really asking how to open a hazel nut using a road roller.

It is a new site; it requires to be incorporated into your Validation Master Plan (VMP) and everything requires to be validated.

Facilities - Utilities - processes - equipment - training - documentation.

Your list is not logical. Be very careful - there are no shortcuts that are acceptable to the regulators. cGMP must be implemented throughout your new facility.

If you use any none validated processes or equipment in the production/testing/storage of your product the regulators may declare your product adulterated.

We could certainly advice you - but you are talking about a large amount of work.

What time scale have you?

Alex

 

[KLDLetts - 2012]

I agree with Alex, your plan will need to be all-encompassing. I am currently working on a validation project that moved production (and related equipment) from one plant to another.
We are validating every thing from Facility - Utilities - Analytical Methods - Process IOQ & PQ and Product Validation along with the required documentation.

The amount of change that your process undergoes in the transfer between plants should have also triggered your re-validation criteria.

 

[lisawxf80]

Thanks Alex.

Our company is aggressively planning everything to be done within few months which I think it must take about years. We have limited resource here. And QA is leading the road.

As such, we could only do the foundamental. As per listed.

Thanks.

 

[lisawxf80]

I agree with Alex, your plan will need to be all-encompassing. I am currently working on a validation project that moved production (and related equipment) from one plant to another.
We are validating every thing from Facility - Utilities - Analytical Methods - Process IOQ & PQ and Product Validation along with the required documentation.

The amount of change that your process undergoes in the transfer between plants should have also triggered your re-validation criteria.

Hi,

Thanks for the advice. May I know more detail your validation master plan has covered. We have no experience ppl here in the company. I hope to do it in a proper way. Appreciate.

Regards,

Lisa

 

[KLDLetts - 2012]

Lisa,

We are in the exact position you are, we have no experienced staff on site and management wants it done as fast as possible but without using any resources. (Which means it will take a very long time to get done...).
We had a consultant visit earlier this month to help us with preparation, and he had us completely gut our VMP. My task this week is to bring it up to snuff, I will post what I can once that is complete!

He did recommend virtually starting from scratch in the VMP and building it as you progress so that you don't get bogged down in the details. For us this meant taking out our other production lines (that we want to validate in the future, but aren't mission critical to bringing the assigned registered products to our facility), and limiting the scope of the VMP to only the IOQ portion for the lines and utilities. Once those are written up, then I will go through the VMP again to add in the required information for the PQ, and then again for cleaning validation, product validation, analytical methods, etc.

 

[v9991]

He did recommend virtually starting from scratch in the VMP and building it as you progress so that you don't get bogged down in the details. For us this meant taking out our other production lines (that we want to validate in the future, but aren't mission critical to bringing the assigned registered products to our facility), and limiting the scope of the VMP to only the IOQ portion for the lines and utilities. Once those are written up, then I will go through the VMP again to add in the required information for the PQ, and then again for cleaning validation, product validation, analytical methods, etc.

1)
if i understand you post, you intend to bring VMP upto IOQ level of details; validate the systems & equipments and then expand the VMP to PQ level of details!!!
Its interesting approach to build upon the MVP in a phased manner; (first IOQ & followed/later add the PQ part) in order to implement this...you might consider additional fail safe requirements for product (which are manufactured during the period of IOQ --> PQ completion); this is usually manageable for lesser-complex products and personnel; But, i haven't seen this approach anytime before. It will be interesting to see how this pans out in context of compliance to regulations, and other areas!!!

I would like to caution you from ignoring the risk assessment;

2)
It might have worked well in your case, because, you seem to have segregated the product specific lines; that seems a practical approach, BUT in case of OPs scenario, they plan to move into new facility (with almost all new systems/equipments in place!!!)

 

[KLDLetts - 2012]

We won't be manufacturing any registered products until all of the validation work up to the product validation is done.

We were also instructed to work on our risk assessment (don't know why I left that out before).

I think my situation is similar to the OPs in that we moved two existing packaging lines from a sister plant to our plant, which necessitated a fair amount of system changes in terms of our utilities, facilities etc. Essentially we are starting from scratch in terms of validation - everything is 'new' to us, as for the OP.

 

[lisawxf80]

Lisa,

We are in the exact position you are, we have no experienced staff on site and management wants it done as fast as possible but without using any resources. (Which means it will take a very long time to get done...).
We had a consultant visit earlier this month to help us with preparation, and he had us completely gut our VMP. My task this week is to bring it up to snuff, I will post what I can once that is complete!

He did recommend virtually starting from scratch in the VMP and building it as you progress so that you don't get bogged down in the details. For us this meant taking out our other production lines (that we want to validate in the future, but aren't mission critical to bringing the assigned registered products to our facility), and limiting the scope of the VMP to only the IOQ portion for the lines and utilities. Once those are written up, then I will go through the VMP again to add in the required information for the PQ, and then again for cleaning validation, product validation, analytical methods, etc.

Hi,

Thanks, that is wonderful. Appreciate that if can view the VMP once you have.

Thanks a lot.

Regards,

Lisa

 

[lisawxf80]

Hi,

Thanks, that is wonderful. Appreciate that if can view the VMP once you have.

Thanks a lot.

Regards,

Lisa

Dear KLDLetts,

Any news for your validation master plan?

thanks & Regards,

Lisa