This article introduces the concept of life cycle applied to process validation and how this idea was already underlying the first FDA reports on the challenges that the pharmaceutical industry had to face in the 21st century.
The three validation stages that, under different names, distinguish both the FDA in its new validation guide for 2011 and the EMA in its 2014 guide and in Annex 15 of the GMPS of March 2015 are explained.
Is detailed the strategy to be followed for the implementation of stage 3 of Continued Process Verification or On-Going Process Verification. It is emphasized that, for those products validated under the traditional approach before March 2015 (“legacy products”), it is also necessary to develop a protocol for Continued Process Verification (CPV) or On-going Process Verification (OPV). For these products, a case study of implementation that Telstar’s Consulting division has developed for a wide variety of products (including solids, liquids, semi-solids and steriles) from a major pharmaceutical company is presented.