As a final thought, FDA has also moved away from statements made in the original 1987 guidance. Among these departures are:
- In the original document, FDA discussed IQ and OQ
- The original document contained definitions of the various validation practices such as prospective and retrospective
- There was definite link to QA by insisting on QA procedures
- It stressed the participation of QA in equipment design and selection
- There was a separate section on medical device preproduction QA activities.
These are only a few of the departures but significant ones.
Over the years, the practice of validation has been truncated, revised, and reinvented. The old standby of IQ, OQ, and PQ
has been criticized by some as not being in step with current technology and evolution of practices. The industry had matured,
it was argued, and to such a point that everyone now understands GXP, or good X (variable) practices, including GEP. Though
the industry has matured, human nature may not have. Problems of quality still occur and recalls still happen.
Table III (continued): ASTM E2500 and FDA draft guidance topic comparisons.
There was really nothing wrong with the original practice of IQ and OQ. Granted, it was in need of improvement and standardization,
especially with regard to scope of activity. FDA has not abandoned the concept of qualification as pointed out in its draft
guidance. To eliminate QA (QU) and rely on verification practices that have not been independently scrutinized is not correct
either. The use of the SME only complicates the practice of qualification even more by requiring another individual for document
approval in place of QA and to make critical decisions. The question to be asked is why the SME could not reside in and be
part of QA? Because the QU was originally intended as the independent observer and reviewer, why couldn't this be the new
Our present situation is complicated by the variety of non-harmonized approaches and standards. If it is not ASTM, it's the
ISO. If it is not the FDA, it's the EU or Medicines and Healthcare Products Regulatory Agency (MHRA). If it is not ISPE, it's
the PDA (Parenteral Drug Association). Even within the regulations, there is inconsistency of meaning and implementation.
ICH Q7A and other documents discuss IQ, OQ, and PQ, but the new guideline only mentions PQ (7).
There needs to be a halt to the reinventing of qualification and validation. Yes, technology improves, and understanding and
practice move forward. In the end, we still have to properly verify through qualification.
Several ideas are listed below for harmonizing the concept and practice of equipment and system qualification and process