Formulation, Development & Delivery In-Depth Focus 2018

The contamination of pharmaceuticals by microorganisms represents a major threat to public health. Regulatory agencies around the world require the absence of certain types of microorganisms that can be considered hazardous to consumers or compromise drug stability and efficacy. Luis Jimenez and colleagues, from Bergen Community College, New Jersey, US, present the results of a real-time PCR analysis used to detect Staphylococcus aureus in pharmaceutical products contaminated with mixed bacterial cultures.

The introduction of ICH Q3D – Guideline for Elemental Impurities – was an additional safety‑based guidance for toxic impurities. Dave Elder, of David P Elder Consultancy, discusses the current status of implementation of ICH Q3D in various regions and the impact on the principal pharmacopoeias. He also looks at analytical preparation, testing and validation as well as specification implications.