ASTM E2500 is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment. It is applicable to equipment, systems/processes, utilities, laboratory systems, I.T. and automation systems that may affect product quality and patient safety.
The ASTM E2500 standard was first published in June 2007, and re-approved in 2012. It is in line with international regulatory requirements like ICH Q8, ICH Q9, ICH Q10 (Pharmaceutical Development/”Quality by Design”, Quality Risk Management, Pharmaceutical Quality System). This approach broadly used in the USA and supported by the FDA, is also being rolled out in Europe, particularly by manufacturers to rationalize their system test phases reduce their Time to Market.
ASTM E2500 has a number of similarities with the traditional V-model process, however the tests to be carried out no longer follow a rigid FAT/SAT/IQ/OQ/PQ sequence as described in EU GMP Annex 15, they are now brought together under the single term “Verification” and can be more rationally organized and efficiently adapted to each context.