The topic of qualification is an integral part in the life cycle of GMP equipment. The classical 4-step model with DQ, IQ, OQ and PQ has become the most widely used one. The basis for the tests within the framework of the 4 steps is constituted by one or several (continuous) impact assessments. In the 4-step model, engineering aspects are often intertwined with GMP aspects. In many cases, the whole procedure is highly documentation-oriented and leads to a strict change management.
Suggestions for modernising this model came e. g. from the ISPE in "risk based qualification in the 21st century". The tenor of it was to place more emphasis on DQ and correspondingly on PQ, in which the DQ requirements are verified. Less impact on the final product is attributed to IQ and OQ. The idea of process orientation, and thus the focus on the final product, runs throughout the whole document. Insofar, the engineering aspects are clearly separated from the GMP aspects. Besides, documentation is not meant to be an end in itself, and quality assurance should be integrated into qualification less rigidly.
This is where a document with the number E 2500 by ASTM (originally known as American Society for Testing and Materials) of 2007 starts from and develops this idea further. When the design has been released by a subject matter expert (SME) - i. e. not necessarily by quality assurance - on the basis of risk assessment, the critical elements are examined within the framework of a verification. Tests that have hitherto been carried out in IQ, OQ, PQ. During verification, this relatively strict distinction gets blurred, on the basis of risk assessments regarding product quality and patient safety. However, there remains a clear dividing line between GMP aspects and engineering activities (Good Engineering Practice, GEP). For this reason, this approach also provides more flexibility with regard to design variations during the verification phase.
The juxtaposition of the classical approach and that of ASTM 2500-07 is shown very nicely in a slide by Lynn Bryan, from the UK-based firm Ballygan.
Lynn gives a lecture at ECA's GMP Education Course "The Validation Manager"in Munich from 10-12 March 2010. Take the opportunity to discuss the possibilities and limits of this new approach with Lynn during this event.
On behalf of the European Compliance Academy (ECA)