Latest FocusThe four pillars of pharmaceutical validation(Free)The four fundamental principles of validation are product and process understanding; data-driven and statistically supported action; multidisciplinary and broad-based methodology; and a holistic approach. With these universally applicable principles, you can develop compliant, effective, and efficient validation programs that suit any situation and that will comply with regulatory expectations.General FeaturesEvaluation of a continuous-cycled film coater in applying a high-solids coating formulationThe study described here evaluated the performance of a novel film coating formulation that can be applied at solids concentrations as great as 35 percent in a continuous-cycled coating process. Four trials were conducted and the coated tablets were assessed for weight gain consistency, color uniformity, surface roughness, and gloss.US-made lactose extends Meggle’s reachDavisco and Meggle join forces to manufacture pharma-grade lactose in Le Sueur, MN.Spotlight on Nutraceuticals: The buck stops where? Clarifying responsibility under quality agreementsDistributors of private-label dietary supplements that rely on contract manufacturers are nonetheless liable for failures to comply with GMP. Learn how to write a quality agreement to ensure compliance and avoid FDA enforcement actions.Eye on Excipients: Sodium starch glycolateSodium starch glycolate has been used as a superdisintegrant in oral solid dosage forms for 50 years. This edition of the column traces SSG’s history, reviews market demand, and summarizes recent applications.
Back Page: Excipient variability: A very big deal sometimes(Free)Making mini-formulations of excipients in the lab and assessing their processability and stability cannot capture the full potential for variability. It’s better to map an API’s susceptibilities to potential degradation pathways, followed by a risk-based assessment that reveals an excipient’s impurity profile.