Near-infrared spectroscopy in compliance with pharma regulations

Near-infrared spectroscopy is recognized by common pharmacopoeias as a secondary method for a fast and reliable, non-destructive analysis in pharmaceutical manufacturing. This White Paper explains how Metrohm solutions comply with regulatory requirements.

Introduction

The pharmaceutical industry is unique with its extensive regulations. Decisions concerning quality assurance are usually made on the basis of regulatory requirements and guidelines. Quality control takes a central role in the pharmaceutical industry. In addition to being robust and reliable, the means of quality control therefore must be maximally efficient. Timesaving secondary methods have therefore come into the focus of both the pharmeceutical industry and regulatory authorities.