• Handling and Micronizing HPAPIs

    There’s no universally agreed definition of what constitutes a highly potent API (HPAPI). But a health-based exposure limit (HBEL) can serve as a more reliable indicator of whether an API is potent or not. However, when evaluating a program, it is advisable to start with the mind-set of “how potent” the API is, then decide “how much” containment it will need. read more
  • Don’t Fear the CAPA: Addressing ‘Prevention’ Early Leads to Fewer Problems Later

    The US Food and Drug Administration’s acronym for Corrective and Preventive Action (CAPA) can fi ll cGMP manufacturers with dread. Phrases like “death by CAPA” and “ineffective CAPA” are common in the manufacturing world. However, a well developed CAPA can be a useful tool organizations can wield to prevent repeat errors and ensure continuous improvement. read more
  • Small Continuity: Applying CM to Wet Granulation and Fluid Bed Drying

    Drug makers have traditionally employed continuous manufacturing for large volumes of a limited number of products. They also prefer direct compression when manufacturing solid dose products continuously. Because of these tendencies, continuous manufacturing systems have been primarily designed for high throughput direct compression. However, some molecules resist manufacture through this method—leading to an interest in continuous systems for wet granulation of solid dose products. ... read more
  • Encouraging Integration: Fostering Relationships Between Formulators, Specialty Chemical Producers, and Excipient Suppliers Creates a Stronger Supply Chain

    Pick up the annual report of any generic pharma company like Teva, Sandoz, Aurobindo Pharma, etc. and it will likely include claims about being an integrated pharma company. But really, what does “integration” mean, to what extent do they do so, and how do they accomplish it? read more