14.06.2022 | LOGFILE Feature 23/2022

How is process validation differentiated from other elements of quality management?

How is process validation differentiated from other elements of quality management?

8 min. reading time | by Thomas Peither


The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.

This is troublesome, but not surprising. After all, the relevant regulations come from very different sources: from authorities in the EU and the USA, internationally active working groups such as PIC/S or ICH, as well as industry associations such as IPEC, PDA or ISPE.

The confusion of terms is compounded by translations that are linguistically exact but not always accurate in terms of content.

If one compares the current definitions of different sets of regulations, a clear discrepancy in content is noticeable. In German legislation, the term validation is clearly limited to processes and standard working procedures. According to the glossary to the EU GMP Guideline Part I, however, validation also comprises equipment and materials – validation is thus used as a generic term and also includes qualification. The EU GMP Guide Part II and also the IPEC GMP Guide for Pharmaceutical Excipients, on the other hand, limit the meaning to processes, methods and systems.

Finally, Annex 15 of the EU GMP Guidelines does not define the term validation in general terms, but does define process validation, which is restricted to manufacturing processes for medicinal products. The same applies to the European Medicines Agency (EMA). So much for the conditions in Europe, which are diverse enough in themselves.

In the linguistic usage of the U.S. FDA, however, the distinctions between qualification and validation become even more blurred. The American authority expands process validation into an overarching term that includes not only process design in the development phase, but also facility qualification and continued process verification during routine production. Moreover, the qualification term is also used here for processes. Process qualification – a neologism that the current European guidelines, i.e. the EMA guideline on process validation and the revised Annex 15 to the EU GMP Guideline, have not yet adopted.

The third word that is appearing more and more frequently is verification. However, it is difficult to draw a clear, sharp distinction between verification and validation, as there is neither a legal definition nor prescribed procedures in the GMP regulations.

Tip for the daily GMP routine

The vagueness and inadequate demarcation on the regulatory side have led to the terms validation, qualification and verification being interpreted very differently in practice and sometimes leading to a hopeless confusion.

In order to avoid misunderstandings within the company, but especially with external contractual partners, it is therefore essential that companies define their own definitions and validation principles.

The validation master plan is best suited for this purpose, which then serves as a common starting point for exchange during qualification and validation activities, but also vis-à-vis authorities.

A translated excerpt from episode 23 of the German webcast GMP & TEA "Valid processes are the core of Good Manufacturing Practice!".

Thomas Peither


Thomas Peither
GMP-Expert and Board Member at GMP-Verlag Peither AG, Schopfheim
E-Mail: thomas.peither@gmp-verlag.com

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