Position Paper: Are We Abandoning IQ and OQ? - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Position Paper: Are We Abandoning IQ and OQ?
The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of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."

Pharmaceutical Technology
Volume 33, Issue 11


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.

Table III (continued): ASTM E2500 and FDA draft guidance topic comparisons.
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.

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 FDA has not abandoned the concept of qualification as pointed out in its draft guidance.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 structure?

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 validation.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here