Where moving packaging machine from one building to another. What type of validation is required?

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Where moving packaging machine from one building to another. What type of validation is required? Do I need to do IQ/OQ/PQ also?

Any help would be appreciated.
Thanks,
Rob

2

Primary packaging? Secondary Packaging? Labels, fill? What ISO/Grade is the machine moving from/to?

3

At a minimum IQ/OQ/PQ again. Also demonstrate the moving did not affect the packaging process.

4

A Validation plan to define the move and to document proposed testing and impact to the new facilities i.e. any room qualification impacts for Micro and particulates, Utility impacts, material flow impacts, any changes in gowning rooms, Training impacts,

Document change Impacts to SOPs etc, ask regulatory if this packaging change has an impact upon the registration of the product.

IQ/OQ/PQ with the difference that the IQ will have change control section( if none performed before) added. You may also want to consider doing a “decommissioning” of the equipment as a verification that the last lot produced ( prior to move) was acceptable ( i.e. in equipment cal, all PM performed, no outstanding change control or major deviations).

Review the documents and see if the docs ( esp the mfg SOP’s) refer to a specific room / site location. That is easy to overlook. Do Risk analysis to see if room need to be re qualified due to added personnel and added operations.
Val Plan is more critica.

Source: LinkedIn Group