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 the 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 signature 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 cost effective global compliance when coupled with advances in information technology (IT).

Calibration management
Calibration management is mandated in 21 CFR Part 211 as a requirement for making reliable measurements in all aspects of development, manufacturing and quality control (QC) of drug products. Because development, manufacturing and QC have become more sophisticated, calibration has become more complex as well. Calibrated assets are found across the pharmaceutical organization, from analytical equipment in development and QC laboratories, to process instrumentation in pilot plants and full-scale manufacturing. A typical pharmaceutical corporate campus may have as many as 20,000 instruments requiring periodic calibration and global, corporations may have hundreds of thousands of GMP critical assets. As a result, calibration problems are always found among FDA 483 observations and warning letters.