Equipment Validation: A New Term at the FDA?

In a recent Warning Letter, the FDA criticised a pharmaceutical manufacturer for missing process validations and deficiencies in equipment qualification. What corrective actions are required?

In its response, the company stated that it had initiated a deviation concerning the missing process validation and had begun validation activities. The management team was re-trained on the relevant SOP.

With regard to equipment qualification, the company stated that a deviation concerning change control had been opened with the aim of amending the relevant SOP. As part of a qualification, the company cited the purchase of a measuring device and a certified temperature sensor.

However, the FDA considered the responses to demonstrate a lack of understanding of what process validation and "Equipment Validation" mean. It requested a comprehensive process validation plan describing, among other things, the number of validation batches, the sampling plan, the analytical methods and the statistical approaches to process capability.

The equipment qualification plan attached to the response was also insufficient for the FDA. The authority made it very clear that simply purchasing a piece of equipment or a measuring instrument is not equivalent to equipment qualification. It therefore expects to see a comprehensive qualification plan, as well as written instructions for the qualification of equipment and facilities.

Conclusion: In the Warning Letter, the term "Equipment Validation" is used synonymously with equipment qualification. The GMP world is "grey"; there is a wealth of individual terms for activities that are often essentially the same. Be flexible!

You can find the full Warning Letter on the FDA website.