Changing the existing validation culture to meet the expectations of the new guidance may be the biggest challenge industry
faces. The guidance requires companies to expand their current scope of validation by reaching further upstream into development
and downstream into day-to-day manufacturing. Companies agree this expansion will foster better communication from the development
groups through to manufacturing but are concerned that it also requires additional staffing. To better understand and meet
this challenge, companies should create gap analyses of their current state of validation and compare it with the future state
based on the new guideline. These gap analyses will better situate companies to create action plans for the new policies and
procedures that may need to be put into place. The analyses will also assist in identifying any resource gaps and training
FDA's new process validation guidance has received generally favorable reviews for its nonprescriptive and flexible approach.
With this flexibility, however, comes a concern about acceptable approaches for implementation at a practical level and a
genuine need for a continued dialogue of explanation and clarification between the agency and industry. Due to limitations,
this article could only touch on a handful of the questions being asked at this time. The authors endeavor to create a series
of articles in Pharmaceutical Technology to further address issues such as the use of risk management along the three stages of validation, collection and transfer
of product and process knowledge along the validation life cycle, and continued process verification.
Dr. Mike Long, MBB,* is director of consulting services, and Walter D. Henkels, Sr., is a consultant, both at ConcordiaValsource. Hal Baseman is chief operating officer of ValSource LLC. Mlong@concordiaValsource.com
*To whom all correspondence should be addressed.
1. FDA, Guidance for Industry: Process Validation: General Principles and Practices (Rockville, MD, Jan. 2011).
2. US vs. Barr Laboratories, 1993.
3. J. M. Dietrick and B.T. Loftus, "Regulatory Basis for Process Validation" in Pharmaceutical Process Validation, R.A. Nash and A. H. Wachter, Eds. (Marcel Dekker New York, NY, 3rd ed., 2003) p. 43.
4. FDA, Guideline on General Principles of Process Validation (Rockville, MD, May 1987, reprinted May 1990).
5. PDA Annual Meeting Post-Conference Workshop, "The FDA's Process Validation Guidance: Meeting Compliance Expectations and
Practical Implementation Strategies" (San Antonio, TX, April 13–14, 2011).
6. ICH, Q10 Pharmaceutical Quality System (2008).
7. FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (Rockville, MD, September 2006).
8. M. Long and H. Baseman, presentation at the Elsevier Business Intelligence Webinar, May 18, 2011.
9. G. McNally, presentation at the PDA Annual Meeting Post-Conference Workshop (San Antonio, TX, April 13–14, 2011).
10. EU, Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 15: Qualification and Validation (Brussels, July 2001).
11. ICH, Q7 Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients (November 2000).