Pharmaceutical companies invest in monitoring systems to assure product quality and to meet government manufacturing requirements. To educate the industry, Veriteq in Vancouver has released a white paper, "Compliance, Risk and Cost of Ownership Comparisons for Pharmaceutical Continuous Monitoring - Wired, Wireless and Standalone Monitoring Systems," available online at no cost.

The white paper discusses five approaches to monitoring critical environments such as pharmaceutical freezers, stability rooms and warehouses. It evaluates each method and presents the risks and cost of ownership for each type.

Agreements between the U.S. Food and Drug Administration and its European Union counterparts regarding pharmaceutical plant inspections will enable stepped-up enforcement of safety guidelines, which will put pharmaceutical manufacturers on higher alert to maintain a best-practice focus on quality systems.

The agreements will help regulators be more efficient with their resources. Mutual agreement among agencies, combined with a focus on risk-based processes, raise the likelihood of more facilities being audited. The agencies will revisit cost vs. benefit analyses for continuous monitoring modalities (wired or wireless networks and standalone monitoring instruments) that facilitate the ability to comply with auditors’ requests for proof of regulatory compliance.

All monitoring methods need to be scrutinized for systemic weaknesses that allow human error to compromise product quality, system failure probabilities and overall costs of ownership.

Access the white paper at www.vaisala.com/veriteq.

Links