The Internal Audit Process: How Your CDMO Keeps Tabs on Its Service Quality

DeAngelo TaborIndustry

When a pharmaceutical company engages a Contract Development and Manufacturing Organization (CDMO) to provide services, the most fundamental assumption is that the CDMO adheres to Good Manufacturing Practices (GMP). What entitles the CDMO to make that promise? The short answer is, it conducts regular audits of its own staff and business processes.

5 Stirring Stability Testing Facts

Tammy Thompson-MadsenIndustry, Testing

People who are not familiar with pharmaceutical development often express surprise and disappointment regarding the time and cost to bring new pharmaceuticals to market. Here are some interesting facts about stability testing:

Chemical Safety Series

Melanie LewisBest Practices, Industry

While finished drug products are intended for eventual human consumption, many of the raw materials and chemicals used to make these products require special safety considerations. Here are some tools to help CDMOs safely manage these important materials:

Transformation Check List – Growing into a CDMO

Amber RileyIndustry

Even with an existing cGMP compliant organization and quality structure in place, bringing on a new service is a big job. Here are some checks to think about when expanding into a new service, specifically aseptic manufacturing: