During the course of their manufacturing, storage, and administration, pharmaceutical drug
products come in contact with materials, components, and systems. Such contact may result …

Several scientific, quality control, and regulatory approaches are used to control and assess
the risk of foreign substances that are inadvertently added to products that humans …

Important safety aspects of compatibility for therapeutic products and their manufacturing
systems, delivery devices, and containers Compatibility of Pharmaceutical Products and …

Pharmaceutical drug products (DP) can contain foreign impurities due to contact with
manufacturing, storage, distribution and administration systems. These foreign impurities …

The issue of extractables and leachables in drugs and packaging is one of the most
complex, challenging, and often (from a regulatory perspective) perplexing in all of …

This chapter explains migration of extractables/leachables from plastic material into a
contact medium such as a pharmaceutical drug product. It depicts the regulatory landscape …

An accelerating trend in the pharmaceutical industry is the use of plastic components in
systems used to produce an active pharmaceutical ingredient or a finished drug product. If …

Demonstrating suitability for intended use is necessary to register packaging,
delivery/administration, or manufacturing systems for pharmaceutical products. During their …

Leachables from pharmaceutical container closure systems can present potential safety
risks to patients. Extractables studies may be performed as a risk mitigation activity to identify …

Single‐use technology has been adopted widely in bioprocess development and
biopharmaceutical manufacture in recent years. While the benefits of such technologies are …