During a validation exercise, it can be difficult to figure out at what stage the process is at. It can be quite chaotic at times with production supervisors, operators, technicians, validation personnel etc are all vying for their own place in the process. Some time ago, we decided that a useful aid in helping communication during the process is to use a whiteboard to list the activities of the day .

For example: Mon 1st February:

Task 1 = Run 1000 placebos through the blister packaging machine to check the formation of the blister pockets.

Task 2 = Run 1000 blister packs through collating machine to check the integrity of the pillow foil.

In this way, mistakes can be eliminated. In one instance during one particular validation exercise, empty blister sheets were run through a machine rather than blisters filled with placebos. About ½ day was lost and needless to say, tempers were beginning to fray!

Validation SOP’s

Another useful tip I have picked up along the way is in the area of writing SOPs from a validation exercise. Those working directly in validation know how difficult it can be to write SOPs from a validation package.

Validation packages can sometimes be composed of hundreds and hundreds of pages of tests and tables of data. Critical information can very easily be omitted from the SOP when writing it. For example, one particular test could be a verification test to ensure that a particular sensor is working correctly. This test may be described perfectly in the validation exercise. However, it could very easily be left out in error from the user SOP, particularly if there is a multitude of other checks than need to be included in the user SOP.

The best way I have found to eliminate this problem is to insert a check at the bottom of each test of the verification process. This check requests that the validation executor indicates whether the test in question should be included in the SOP. It is very easy as a result, upon review of document, to see what should be included in the user SOP.

This has been approached in a different manner by one company where I have worked. In this case, the company used colour for a page in the validation package that was critical to the writing of the user SOP. This practically eliminates the risk of omitting critical items when it comes to writing the user SOP.

Whatever the method of approaching the problem, recognising that there is a risk is half-way to solving it. The risk itself should be identified in the risk analysis which must be performed as part of the validation protocol development.

Author: Stephen Corkery
Title: Validation Specialist
Email: corkerys@eircom.net