New GMP-Guide on Qualification Approved by the ASTM

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:

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

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

Interestingly the ASTM compares its Guide with regulatory guidelines. It alsomentions 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. Itis 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%.

To find details on the Guide please visit the ASTM Website.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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