Establishing Global GMP Compliance with an Enterprise Calibration Management System

Driven by tough FDA enforcement, attention to GMP compliance is at an all-time high. In addition to having the responsibility for complying with increasing regulatory requirements, pharmaceutical manufacturers must find ways to improve their productivity.As a result
of mergers and acquisitions, worldwide markets, and the complex nature of drug development, the need for cost-effective global compliance has never been more important. FDA itself has acknowledged the changing times and has been working with industry to support new technologies for safe and cost-effective compliance. Two such initiatives are the electronic
records and electronic signatures rule, 21 CFR Part 11, and a new program titled “Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach” (available at www.fda.gov/oc/ guidance/gmp.html), which are paving the way for productivity gains for manufacturers while allowing FDA to continue its quest for public safety. These activities are providing companies the opportunity to evaluate and improve their good manufacturing practices (GMP) management systems. Calibration management is one such GMP system that can readily take advantage of new regulatory advances. This article discusses how calibration management systems (CMS) can enable costeffective global compliance when coupled with advances in information technology (IT).

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