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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTECHNOLOGY/APPLICATION

A Risk-Based Approach to Scheduling Audits

Stephan Rönninger and Holmes Malcolm
PDA Journal of Pharmaceutical Science and Technology November 2009, 63 (6) 575-588;
Stephan Rönninger
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Holmes Malcolm
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Article Information

vol. 63 no. 6 575-588
PubMed 
20169864

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online November 25, 2009.

Copyright & Usage 
© PDA, Inc. 2009

Author Information

  1. Stephan Rönninger* and
  2. Holmes Malcolm**
  1. *Global Quality Manager, F. Hoffmann-La Roche Ltd., Postfach, Bau 657/23.020, CH-4070 Basel, Switzerland. Phone: +41-61-68 86 974. Fax: +41-61-68 88 892. E-mail: stephan.roenninger{at}roche.com and
  2. **Hillborough House, Chapel Hill, Speen, Princes Risborough, Bucks. HP27 0SP, United Kingdom. Phone: +44-1494488354. E-mail: malcolmbrian.holmes{at}tiscali.co.uk
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    PDA Journal of Pharmaceutical Science and Technology: 63 (6)
    PDA Journal of Pharmaceutical Science and Technology
    Vol. 63, Issue 6
    November/December 2009
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    A Risk-Based Approach to Scheduling Audits
    Stephan Rönninger, Holmes Malcolm
    PDA Journal of Pharmaceutical Science and Technology Nov 2009, 63 (6) 575-588;

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    Stephan Rönninger, Holmes Malcolm
    PDA Journal of Pharmaceutical Science and Technology Nov 2009, 63 (6) 575-588;
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    • Article
      • Abstract
      • 1. Introduction and Scope
      • 2. The Auditing Process
      • 3. The Process of Establishing a Risk-Based Audit Plan
      • 4. Experience with This Procedure
      • 5. Conclusion
      • Acknowledgments
      • References
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    • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
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