Welcome To The Party Compounders!

The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section... Read more

The Coming Evolution of Quality Management Software — Maybe.

I had an interesting phone call today with a company named ZenDoc — www.getzendoc.com — a software company, headquartered in Dublin, Ireland.   The company contacted me to introduce me to their "new" document management software that in their words,... Read more

New FDA Inspections’ Database — How Useful for FDA-Regulated Industry?

The new Inspections Database (http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm) is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement actions and results across the country and rest of world. It is certain... Read more