Tuesday, December 25, 2007

The ASTM E2500 Standards..a go to "V"alidations!!!

The adoption of E2500 standards by ASTM is a go to "V" model approach of Validations?? The E2500 standards are adopted by ASTM committee E55 in May 2007. The E 2500 standards titled as "A Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipments"
As there are aspects of qualification that add value in terms of ensuring the equipment and systems are ready to reliably manufacture a quality product; there are other aspects and documentation practices that clearly do not add this value. The basis of this standards is that the rigid rules that surrounds qualification (as practices today) can detract from its overall effectiveness.
The big change comes in the verification stage during the qualification process of this approach. ASTM E2500 states that verification is "A systematic approach to prove that critical elements acting singly or in combination, are fit for intended use, have been properly installed, and operating correctly". This verification would normally be documented in IQ, OQ and PQ documents however, the new approach just states that the verification approach must be documented. The extent of verification and the level of detail of documentation should be based on risk to product quality and patient safety. This approach also allows more flexibility if the design changes before the final acceptance with GEP change managed by and approved by subject matter expert (generally engineers).
After acceptance, GMP change is managed and approved by Quality. So another key factor of this approach is that things change and as long as they are managed and documented correctly this is acceptable.
While ASTM standard E2500 does much to eliminate the "folklore" wasteful practices such as excessive focus on documentation practices that have come to permeate qualifiaction, it also contains provisions that are not typically part of many projects, or if used, aren't given as much attendion as "GMP requirements", specification and design reviews, risk management and application of good engineering practices.

More information on ASTM E2500 can be taken from here.

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