GHTF Guideline on Process Validation

Since the publication of the Guideline on Process Validation in 1987, the FDA has added only few concrete requirements regarding process validation.

Therefore, it is worthwhile having a look at the requirements on medical devices. The Global Harmonization Task Force (GHTF) has revised its existing Process Validation Guidance. The members of this organisation are representatives from industry and authorities. It was founded by the EU, the USA, Japan, Australia, and Canada and aims at the harmonisation of requirements on medical devices.

The revision was necessary as the requirements on the validation of medical devices via ISO 13485:2003 had to be integrated.

It is an interesting fact that the guidance also covers the qualification activities (IQ to PQ). It is perfectly possible to transfer the details on validation plans described in the guidance to the pharmaceutical industry.

Another interesting feature of this document are the annexes. Annex A lists tools that can be very helpful for process validation. Among them are e.g. statistical methods, but also methods for risk analysis, like FMEA or FTA.

Annex B provides a real-life example for a validation plan. It includes examples for the documentation of IQ-, OQ- and PQ results and for the "Final Report."

The document can be viewed here.