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Auditing Process Validation & Developing Protocols


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from Rob Packard at OMTEC 2014

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Have you ever had to perform a process validation protocol for a new piece of equipment or acquired a process that was not properly validated?

If not, consider yourself lucky. However, you can be certain that there is a manufacturing engineer a few cubicles away who still has nightmares about a similar experience. Ideally, new equipment purchases include the purchase of an equipment validation template from the manufacturer—probably at a purchase price of thousands of dollars. Usually, the validation templates are a waste of money and the resulting process validation is inadequate.

How to perform an internal audit or supplier audit of process validation:

Auditing process validation is a logical opportunity for using the process approach to auditing, but most auditors use a checklist. Typically, I see lame questions like this:

1. Did you validate the process?
2. Have you made any changes to the process?
3. Have you moved the equipment?
4. Is the process operating within the validated range?

First of all, all of these questions can be answered with a yes/no response. Even the most experienced auditee is not likely to respond with anything other than the word “yes.” If you are a competent auditor, you will ask for records. For example, a typical completed audit checklist:


What to Look at What to Look for Notes

 820.75 -  process  validation

Validation Protocol
and Report

IQ/OQ/PQ for
automated equipment

Combined IQ/OQ (PV-123-1) was performed at the time of installation and three PQ lots (PV-123-2) were performed at the nominal temperature setting.      

 820.40 -
 control of  documents

Process work instructions and the Device Master Record (DMR)

Changes in the revision history for the process work instructions or the DMR

No process changes are indicated in the work instruction revision history.   

 820.70g -  equipment  and  maintenance

Maintenance records

Location of equipment and non-routine maintenance

The equipment is the same location that is indicated in the validation report.

 820.70b -  production  controls

Device History Record (DHR)

Actual operating range used

Temperature of sealer was set 300F for lot 123. This is the nominal temperature indicated in the DMR.

Here’s how a process audit would be performed. First, the auditor would interview the manufacturing engineer who was responsible for validating the equipment. She would complete a turtle diagram to document the various inputs and outputs of the validation process. The resulting turtle diagram might look like the figure below (if she read last year’s article on Adjacent Link Auditing):