Application Note: Satisfying GMP With Handheld Near-Infrared Analyzers In The Pharmaceutical Industry

Pharmaceutical manufacturing is a highly regulated industry as manufacturers of excipients, actives and finished forms need to conform to GMP. For example, in the European Union, EudraLex provides guidance for GMP practices and European Pharmocopeia (Ph. Eur.) recommends instrumentation and analysis protocols. In the United States, the FDA provides guidance for GMP and electronic record keeping under 21 CFR 210 and 11. Implementation of international harmonization has been effective in allowing the flow of materials across national borders. Given the increased demand for GMP and 100% inspection, the use of convenient and reliable handheld near-infrared (NIR) analyzers has proven to be a successful solution for inspection and compliance in the pharmaceutical industry.

From a production standpoint, following GMP has clear benefits. It is readily apparent that the quality and quantity of the active ingredient must be controlled. The "inactive" ingredients play an essential role in protecting and releasing the active ingredient under the appropriate conditions. Even low-concentration excipients may play a significant role in the release of the active As the manufacturing process is tuned to producing millions of doses that perform within stringent limits, the ingredients must have predictable physical properties. Monitoring the raw materials and the finished products at-line during production runs allows processes to be implemented that ensure a more consistent product and increased efficiency.