Risk Mitigation in High-Potency Manufacturing

A recently released industry guide outlines a science- and risk-based approach to control the risk of cross-contamination.
Oct 02, 2010
Volume 34, Issue 10

Patricia Van Arnum
Cross-contamination is an ongoing concern in pharmaceutical manufacturing and is of particular importance in environments in which high-potency compounds are manufactured. The recently released Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Baseline Guide by the International Society for Pharmaceutical Engineering (ISPE) provides a scientific risk-based approach, predicated on the International Conference on Harmonization guideline (ICH) Q9 Quality Risk Management, to manage cross-contamination in order to achieve and maintain an appropriate balance between product quality and operator safety.

History of Risk-MaPP

The process for Risk-MaPP began in 2004 when the basis of future dialogue between the US Food and Drug Administration and industry members emerged following an ISPE conference in which it was suggested that FDA may consider treating potent compounds similarly to the controls required for penicillin: that is facilities manufacturing potent compounds would need to be dedicated or segregated. That consideration led select industry members to present information at a subsequent ISPE conference in 2005 to show "how science could be used to control the risk of contamination," says Stephanie Wilkins, president of the consulting firm PharmaConsult Us (Bridgewater, NJ), cochair of the ISPE Risk-MaPP Baseline Guide Task Team, and former member of the ISPE International Board of Directors.

In 2006, industry members met with FDA to further discuss a science- and risk-based approach for controlling cross-contamination. "FDA was very receptive, and at the conclusion of this session, FDA agreed to work with ISPE to develop a document on the subject," says Wilkins.

In addition to advocating for a science- and risk-based approach with respect to controlling the risk of cross contamination, the ISPE Risk-MaPP Baseline Guide Task Team also recognized the importance of harmonizing global regulations with respect to dedicated facilities, compounds, and cross contamination. The task force offered input and its draft documents to the European Medicines Agency's (EMA) Dedicated Facilities Working Group as that group considered draft revisions to the European Union's guidelines on good manufacturing practices (GMPs). "We believe that our efforts helped EMA's Dedicated Facilities Working Group move their draft revisions to the EU GMPs more toward a risk-based approach rather than a laundry list of compounds or classes of compounds that would require dedicated facilities," says Wilkins.

The ISPE Risk-MaPP task force also sent draft copies of to the World Health Organization and the national regulatory agencies in Canada (i.e., Health Canada), Brazil (Agência Nacional de Vigilância Sanitária, or National Health Surveillance Agency), and Switzerland (Swiss Medic) and considered and incorporated any comments it received into the final version of Risk-MaPP.

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