Analytical Quality Control News

The validation of analytical methods is an essential component of Good Manufacturing Practice (GMP). It provides documented evidence that an analytical procedure is suitable for its intended purpose and consistently generates reliable, reproducible, and robust results under defined operating conditions.

Stability studies are the scientific cornerstone for understanding how the quality of an active substance or medicinal product evolves over time when exposed to environmental factors such as temperature, humidity, and light. Thoughtfully designed and consistently executed stability programs are essential – not only to meet regulatory expectations, but also to support robust lifecycle management and enable confident, risk-based decision-making.

In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) identified significant weaknesses in laboratory controls, missing analytical validation, and an inadequate stability program.

The 'Reflection paper on the qualification of non-mutagenic impurities' was published on the EMA website at the beginning of February 2026. It is intended to supplement the existing guidelines for non-mutagenic impurities (NMI) with regard to qualification and safety assessments.