Conclusion
The CbD approach provides an organized and focused approach to quality systems and compliance based on proven successful and
acceptable methods. This approach should facilitate a proactive evaluation of compliance performance against compliance attribute
standards. Implementation should provide multiple benefits to the organization. An organization that embraces the CbD approach
demonstrates a strong commitment to current good manufacturing practice compliance and increases the credibility of the compliance
effort with auditors.
Paul L. Pluta, PhD,* is a an adjunct associate professor at the University of Illinois at Chicago College of Pharmacy in Chicago, IL, and editor-in-chief
of the Journal of Validation Technology and the Journal of GXP Compliance, published by Advanstar Communications, paul.pluta@comcast.net
. Richard Poska is director of Abbott Pharmaceutical Products Group Regulatory Affairs at Abbott, Abbott Park, IL. Timothy J. Fields is senior director of quality operations at the Protein Sciences Corporation, Meriden, CT.
References
1. L. Yu et al., Pharm. Technol.
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2. FDA, Guidance for Industry, Process Validation: General Principles Practices (Rockville, MD, January 2011).
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14 (5), 10–13 (Autum 2008).
4. M. Gladfelter, J. Validat. Technol.
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6. R. Nash, J. Validat. Technol.
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7. M.M. Borkar, A. A. Shirwaikar, and P.G. Shilotri, J. GXP Compliance
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*Part one of this commentary, "Compliance by Design (CbD) and Compliance Master Plan (CMP)–An Organized Approach to Compliance,"
was published in the Journal of GXP Compliance 14 (2), Spring 2010.
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