Compliance by Design and Compliance Master Plan - Pharmaceutical Technology

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Compliance by Design and Compliance Master Plan
The authors review a compliance-by-design approach to quality systems.

Pharmaceutical Technology
Volume 35, Issue 3, pp. 90-96


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,
. 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.


1. L. Yu et al., Pharm. Technol. 33 (9), 122–127 (2009).

2. FDA, Guidance for Industry, Process Validation: General Principles Practices (Rockville, MD, January 2011).

3. T. Miller, J. Validat. Technol., 14 (5), 10–13 (Autum 2008).

4. M. Gladfelter, J. Validat. Technol. 15 (1), 16–22 (Winter 2009).

5. J. Pawlik, J. Validat. Technol. 15 (2), 63–67 (Spring 2009).

6. R. Nash, J. Validat. Technol. 12 (2), 86–90 (February 2006).

7. M.M. Borkar, A. A. Shirwaikar, and P.G. Shilotri, J. GXP Compliance 9 (2), 144-153 (January 2005).

8. FDA, Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations (Rockville, MD, September 2006).

9. L. Torbeck, J. GXP Compliance 15 (1), 13–15 (Winter 2011).

*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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