The GMP News from 17 May 2006 already reported about the draft of the Guide on Qualification by the American Society for Testing and Materials (ASTM). It is entitled "Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (E2500-07)".

In a two-page document the ASTM announced, that the document is now approved, and introduces it by seven questions:

1. What is ASTM; What influence has it on the GMP-regulated pharmaceutical industry?
2. What is the content of this "Standard"? What is the regulatory impact? Is it accepted by the regulators in US and Europe?
3. What is the definition of "verification?"
4. Does the standard have influence on the relationship between the customer and the supplier?
5. How can you use it in the field of CV?
6. Does it have any influence on GAMP 5?
7. Does the new approach reduce the costs of qualification/validation?

The Guide concentrates on reducing IQ and OQ activities through a risk and science based approach, which also takes into account supplier documents. In addition, the society also considers Good Engineering Practice (GEP) to play an important role for reducing cost.

Interestingly the ASTM compares its Guide with regulatory guidelines. It also mentions the US Food & Drug Administration (FDA), which, according to ASTM, supposedly knows the document. There are no comments on the guide from European authorities though.

Moreover, the concept is also considered as usable for computer validation. It is mentioned, though, that it will be incorporated in GAMP 5.

Taking full advantage of the concept for qualifications is supposed to allow cost reductions of up to 50%.

Mehr zu dem ASTM-Dokument finden Sie in einem Q&A-Dokument von David Selby, das Sie hier finden.

To find details on the Guide please visit the ASTM Website or click here to read a Q&A document prepared by David Selby.