Regulatory Issues in Chromatographic Analysis in the Pharmaceutical Industry

Abstract

The pharmaceutical industry is regulated by governmental agencies to ensure that the drugs manufactured possess the correct identity, strength, quality, purity, and potency. One aspect of this regulatory oversight is the drug application process. Analytical methods are a necessary part of the drug application and may be used to generate data for acceptance, release, stability, or pharmacokinetic studies of the pharmaceutical material. These analytical methods provide assurance that the material produced meets the required specifications. Analytical method validation provides documented evidence that the methods used to analyze raw materials, in‐process samples from work in‐progress, or finished product give consistent results. The regulatory requirements for analytical method validation depend on both the objective of the analytical procedure and the stage of drug development. This article presents a review of the requirements and guidelines available for the pharmaceutical industry on chromatographic methods. The methods covered include those for main components and those for impurities. Analytical methods described in regulatory submissions should be validated, as appropriate, and performed on instruments that have been qualified. Hence, this article discusses these aspects of chromatographic methods.

Keywords:

• Chromatographic analysis
• Pharmaceutical industry
• Regulatory issues
• Drugs