A defining issue

As previously introduced, BioPharm will set aside small sections of upcoming issues to identifying common ground amid conflicting uses of certain terms. You will find these sections in our Info+ news department, as article and column sidebars, and sometimes as subjects of whole articles and tutorials. We are on the lookout for terms that are confused with one another and/or used differently by representatives of various disciplines within the biopharmaceutical industry. We hope to build a glossary on our Web site that is dynamically supported by your contributions to the discussions - both in the magazine and (we hope soon) through an online reader forum.

In one of those serendipitous events eerily common to our article acquisition efforts, most of the articles in this issue present some focus on definitions: Bob Seely defines critical variables; Grant Hodgson defines suiteps underlying facility validation; Howard Eisenberg begins a series on "Patent Law You Can Use" by distinguishing between patents, trade secrets, copyrights, and trademarks; Barbara Immel identifies "The Forgotten GLPs"; and Dave Jensen refines his earlier definitions of leadership styles. Additionally, with this issue we are beginning to use running heads that identify where article subjects fall within the larger development process, and this also will lead to an occasional sidebar of definition and explanation.

The plan to build a glossary took on further urgency when a number of readers questioned conflicting uses of the terms validation and qualification in our November issue. We thank Robert Nash of St. John's University (Jamaica, NY) for putting it succinctly:

The titles of the articles by Odum, Cloud, and Huber in your November 1998 issue are confusing. I can't figure out when to use the term qualification and when to use the term validation.

1. Odum in his article talks about using an IQ checklist, but the title speaks about solving a validation challenge by integrating design qualification (DQ), construction, and validation.

2. In Cloud's article, outside of the refrigerator-freezer manufacturer's responsibility to validate the product/process, the customer's QC laboratory should qualify their equipment in their pursuit to validate their analytical methods. Customer qualification of the refrigerator-freezer should include design qualification, installation qualification, operational qualification, and performance qualification, to which may be added maintenance qualification and vendor qualification. I see no validation program here.

3. I have no problem with Huber's approach to HPLC equipment qualification, but the industry for at least the past 10 years has talked about analytical methods validation or systems qualification.

Responses from Cloud and Odum indicated that they were both discussing qualification but used the term validation because it was simply more familiar. That answer left me spinning my wheels for a time, wondering how best to proceed. As editors, we try to ensure that we and our authors define terms as necessary and use them in ways that appear consisuitent. In this particular case, I wondered, can the terms be totally separable? Can the validation of a process always be distinguishable from the qualification of the equipment or sysuitems used in (or even designed specifically for) that process? (As my equestrian associate editor puts it, are the horse and the ride the same thing?) And more to the point for us: Are we editors always going to be alert enough to notice when such terms are confused or misused?

Of course not. There are four of us and over 20,000 of you: We can't promise to define every term to everyone's satisfaction every time. So I was pleased when - again, totally coincidentally -- Ludwig Huber chose this issue's tutorial section to highlight the meanings of validation, qualification, verification, and related terms. By drawing a number of his examples from computer validation terminology, he illustrates both the complexity created by a lack of standardization and the inescapable influence of one discipline on another.

Please consider our "defining moments" as starting points for discussion rather than an attempt to etch definitions in stone. As BioPharm and the biopharmaceutical industry (and the language, inescapably) continue to evolve together, we count on you to bring inconsisuitencies to our attention and to point out areas in need of further examination. Remember that any good dictionary balances actual use against authoritative (and accepted) references: If you take issue with a definition or propose a different view of a term, please let us know. Include references and examples (when possible). Together we may not always find consensus, but we should be able to settle on common ground.

[Author Affiliation]

S. Anne Montgomery amontgomery@advanstar.com