Disposables Qualification And Process Validation

Disposables Qualification
and Process Validation
Managing Risk to Address Leachables, Extractables, and More

Validation or qualification?
According to our growing
online glossary and the many
sources that have gone into its
creation so far, these terms are related
but quite distinguishable from one
another (1). Validation is documented
proof that a procedure reproducibly
gives acceptable results. And
qualification is documented evidence
that equipment is correctly installed,
does what it is intended to do, and
continues to operate within specified
parameters over time. Yet time and
again we see references to “validation
of disposable systems.” People still
want to validate objects rather than
processes, and the concept of
qualification seldom comes up. As I
researched the topic of leachables and
extractables testing, which grew into
the more general subject matter
presented here, I found that the
confusion continues. And I made the
decision to be strict about my own use
of this terminology: Production
methods using disposable components
are validated; the components
themselves must be qualified.