Agency Data Reporting as represented in the structure indicates the information that would be included in regulatory agency databases to monitor product delivery. Utilizing a dashboard type of communication, agencies can be notified of negative performance trends in quality, safety, Asset performance or supply chain delivery. Manufacturers would also be monitoring trends prior to data submission, and can provide explanations and action plans where appropriate to address negative trends. Consistent or positive performance that is trending in-line with product demand from the market would not require specific review or explanations.
From the FDA Strategic Plan for Preventing and Mitigating Drug Shortages, the identified tasks can be addressed through risk-based asset management with the following actions:
Preventing drug shortages is about effectively managing risks and utilizing data-based leading indicators to generate warnings early enough to take corrective or mitigating actions. While the overall supply chain will present added complexities from wholesalers, pharmacies, hospitals and healthcare providers, the Drug Shortage Prevention Program structure proposed brings forward key benefits of focusing on risk-based asset management. Improving the reliability of physical assets provides the foundation for operational stability, maintains a focus on product quality and patient safety, while addressing the manufacturing risks associated with drug shortages.
1. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Quality Risk Management Q9, Current Step 4 version dated 9 November 2005, www.ich.org.
2. ASTM E2500-07(2012): Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, www.astm.org.
3. ISPE Baseline Guide Volume 5: Commissioning and Qualification, International Society for Pharmaceutical Engineering (ISPE), First Edition, March 2001, www.ispe.org.
4. Public Law 112-144, Section 506C(h)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 21 USC 356c(h)(2), as amended by Title X of FDASIA, www.gop.gov.
5. Information regarding the International Society for Pharmaceutical Engineering (ISPE) Drug Shortage Initiative and Task Force can be found at: http://www.ispe.org/drug-shortages-initiative.
6. Berg N, Kos K, et al. Report on the ISPE 2013 Drug Shortages Survey. June 2013. Tampa, FL: International Society for Pharmaceutical Engineering. Available at www.ispe.org/drugshortages/2013JuneReport.
7. BSI PAS 55: British Standards Institution Publicly Available Specification 55-1:2008: Specification for the Optimized Management of Physical Assets, www.bsigroup.com.
8. ISO/FDIS 55000: Asset Management – Overview, Principals and Terminology, www.iso.org.
About the Author:
David J. Mierau, PE, CMRP is a licensed Professional Engineer and Certified Maintenance and Reliability Professional with a broad range of technical and management experience within the pharmaceutical and biotech industries. He is a member of ISPE and the Society for Maintenance and Reliability Professionals (SMRP). David is currently a Senior Reliability Engineering Subject Matter Expert with Life Cycle Engineering providing asset management, reliability, root cause analysis, and engineering management consulting services. He can be reached at dmierau@LCE.com.