News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts. WEEKLY
The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."
Nov 2, 2009 By:
Louis A. Angelucci Pharmaceutical Technology
Volume 33,
Issue 11
Another program promulgated by FDA, was the system approach to facility inspection. With each inspection, which is also predicated
on risk, FDA would concentrate on different quality systems. The frequency and depth of inspections would be determined by
conclusions of previous establishment inspection report (EIR), the Form 483 observations, and/or warning letters a firm may
have received in the past. One of the systems is facility and equipment. After reviewing the FDA validation guidance, it is
apparent that there will not be an immediate surge toward adapting the ASTM standard as common practice. The risk, in this
author's mind, is much too high.
Table I: Document similarities
Even though FDA has not abandoned the concept of qualification, it states that the verification is to be achieved through
qualification. In the ASTM standard, the word qualification is not used and instead we find just the word verification. In
this author's mind, verification is one step removed from qualification, and these words are not necessarily interchangeable.
Definitions and summary
Verification. The act of reviewing, inspecting, testing, etc., to establish and document that a product, service, or system meets the regulatory,
standard, or specification requirements.
Table II: Document differences
Qualification. The process of certifying that a certain product has passed performance and quality-assurance tests or qualification requirements
stipulated in regulations such as a building code and nationally accredited test standards, or that it complies with a set
of regulations governing quality and minimum performance requirements.
Table III: ASTM E2500 and FDA draft guidance topic comparisons.
As a summary, the Table II provides some simple comparisons regarding the major similarities and differences between these
two documents. Though they may seem to be quite similar, the similarities are in word only, but not necessarily in content.
The differences between these documents are even more striking. The FDA participated in the generation and review of not only
the ASTM standard, but also the ISPE commissioning and qualification (C&Q) guide. In the future and once either the rewrite
or the new Guide number 12 is complete, FDA will once again be called upon to give its opinion and review. Table III shows
a comparison of major topics covered in both ASTM E2500-07 and the FDA draft guidance document.
Louis A. Angelucci is the director of corporate validation at MedImmune, One MedImmune Way, Gaithersburg, MD 20878, tel. 301.398.2949.
Articles by Louis A. Angelucci
Survey
What is the single greatest threat to maintaining manufacturing processes at your facility?
