Equipment Relocation & Validation Approach

GOOD VALIDATION PRACTICE (cGVP)
1

Hi,
I am involved in a project in Joburg, where the equipment in the facility were relocated and asked me to Qualify and Validate the plant. Can anyone suggest me the approach towards qualification and validation. More over most of the equipment are not having manuals, urs, drawings…

Regards,
Anil

2

Mmmm sounds like a difficult project to begin without any manuals etc.

You will have to perform retrospective validation on the equipment, so you will have to speak to people who understand exactly how the equipment’s work then write a URS.

Your starting point for each equipment type is a URS.

Is there anyway you can get your hands on any of the manuals?

Regards

3

Normaly you would do a risk analysis on the impact of the transfer on the validated state. This will determine the requalification need.

  • An IQ is minimum to verify the instalation at the new location is appropiate
  • The equipment must be calibrated prior and after the move, to assess the impact of the transport

However, in this case, there is no validated state. In that case you need to conduct the full required qualification program. For the qualification you may use available quality data (retrospective validation) as long as you can justify that these data are still applicable to the new location.
I would not bother too much with the URS, as you do not select new equipment. The suppliers manual and specifications may suit for that. Except for complex systems, where the URS is benificial in formulating the qualification tests.

Regards,

Jan van der Kuil
Quality Business Support

4

I was involved with a similar scenario with one of the top pharma multinationals. In the long run, you will be better off:

  1. going back to basic Good Engineering Practice, develop an Equipment Spec using an “as found” approach to the acceptance criteria for that equipment. This will be the basis of your qualification

  2. carryout a “gap analysis” - comparing current site validation policy to what you have (or dont have); dig up historical trend eg deviation reports specific to the equipment. Use a Risk-based approach to determine the scope of your qualification. Less effort is required if the equipment has been used in manufacturing consistently “good quality” products and is well maintained (substantiated).

Whatever the strategy, ensure you have the buy-in from senior management or corporate quality unit.

Good Luck
Ray