Qualification Guideline ASTM E2500 revised

Recommendation

2/3 May 2024

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The American Society for Testing and Materials (ASTM) norm is one of the requirements referred to when it comes to qualification (and validation). The norm in question has number E2500 and is entitled "Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment". In our GMP News dated 17 December 2007, we reported about the release of this norm.

The ASTM norm represents the further development of a "White Paper" from the International Society of Pharmaceutical Engineering (ISPE) on risk-based qualification and should offer a more modern approach of qualification. The classical qualification levels DQ, IQ, OQ, PQ are not mentioned anymore but Subject Matter Experts (SMEs) who should take care of the organisation of verification. Moreover, Good Engineering Practice (GEP) is highly valued. This ASTM norm is also mentioned in a footnote of FDA's latest Guidance on process validation from 2011.

ASTM E2500 has now been revised and is now available as "reapproved". However, the newly published guide contains no significant changes. The changes made are rather changes in the form. Thus, those already owning the 2007 version do not necessarily need to purchase the "reapproved" version (as the norm is subject to charges). However, if you are not familiar with the ASTM norm you may want to think about purchasing it. It is available on the ASTM website as well as on the Beuth Verlag.