Validation of dissolution test procedures (Free)
This article discusses the reference documents for the validation of dissolution, as well as a general chapter developed by the US Pharmacopeia (USP) and introduced in 2006 that covers the typical analytical characteristics to be evaluated and the procedures by which to evaluate them.

Measuring water activity as a means to reduce microbial limit testing
Water content has long been recognized as an important parameter in determining the safety and stability of pharmaceuticals. Water activity, however, is relatively new to the pharmaceutical industry, even though it has been used extensively in the food and cosmetic industries as a means to reduce the risk of microbial contamination. This article defines water activity and describes why it should be employed in pharmaceutical formulation and testing.

Beware the purchasing manager
Raw material variation often causes production problems, and a common source of variation occurs when purchasing managers buy ingredients based on price alone. This brief article tells you what information to provide purchasing managers so that they specify the correct raw material.

Environmental monitoring systems: Overview and the path toward validation
This article provides an overview of the components of an environmental monitoring system and discusses the path to follow to qualify and validate the system to comply with current Good Manufacturing Practice (cGMP).

Eye on excipients: IPEC regulatory conference
The International Pharmaceutical Excipients Council (IPEC) held its Regulatory Affairs Conference September 15-16 in Alexandria, VA. This edition of the column presents some highlights.