• Back Page: To Gel or Not to Gel?

    For more than a century, empty hard capsules have been a safe, effective dosage delivery system. However, half a century in, recognizing that although gelatin was ideal for hard capsules, it was not perfect, a large pharmaceutical company patented a hard capsule manufacturing process using a modified water-soluble form of plant-derived cellulose. At the time, in an industry completely based on the performance and characteristics of gelatin hard capsules, the challenges of this new “veggie” ... read more
  • An FDA Inspection Tool Kit: What to Expect When Being Inspected

    A list of resources to help prepare for an FDA inspection. read more
  • Preparing for an FDA Inspection? Expect the Unexpected

    An FDA inspection can be one of the most stressful parts of doing business. And while drug pre-approval and pre-license inspections—and most foreign facility inspections are generally pre-announced—FDA does not pre-announce “for cause” and routine domestic surveillance inspections. read more
  • Making Waves

    One stone tossed into water creates many ripples. Sometimes those ripples reach farther and impact more things than the thrower initially intended or realized. Such is the case when the US Congress passed the Drug Quality and Security Act November 27, 2013. The intent was to protect consumers from counterfeit, stolen, contaminated, or harmful drugs. read more