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.
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.
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
Free White Paper Addresses Pharmaceutical Monitoring
January 7, 2011