Over the years, the practice of validation has been truncated, revised, and reinvented. The old standbys of IQ, OQ, and PQ
have been criticized by some as not being in step with current technology and practice. Many in industry argued that most
people understood GXP, including GEP. Although the industry may have matured in this sense, human nature may not have. Quality
problems and recalls still occur.
FDA has not entirely abandoned the concept of qualification as pointed out in its draft guidance on process validation. But
relying solely on verification processes and eliminating the role of QA and QUs is not enough to ensure quality. The current
situation is further complicated by the variety of unharmonized approaches and standards throughout the global industry. Even
within existing regulations, there is inconsistency of meaning and implementation.
Some potential solutions include:
- Involving QA from the onset to participate in the review and acceptance of vendor documentation and the commissioning and
verification of related documentation.
- Commissioning and verification testing for every applicable system. Testing should be completed with a QA reviewer and approved
in a closeout report
- Above all, requalification and revalidation should take place as needed and when necessary.
Louis A. Angelucci is the director of corporate validation at MedImmune, One MedImmune Way, Gaithersburg, MD 20878, tel. 301.398.2949, firstname.lastname@example.org
1. FDA, Draft Guidance for Industry—Process Validation: General Principles and Practices (Rockville, MD, Nov. 2008).
2. ASTM, Standard E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing
Systems and Equipment (West Conshohocke, PA, 2007).