Featured Articles

  • The Critical Role of Granulation in Optimizing Drug Formulation

    Although not yet a routine manufacturing step, granulation plays a central role in determining the quality, consistency and performance of modern OSD products. This article explores how granulation can effectively underpin formulation to transform complex powder formulations into stable, scalable and bioavailable drugs. read more

  • Digital Twin-Driven Scale-Up of Tablet Film Coating

    Scaling up a tablet coating process from work performed with a small-scale unit to a full-scale production plant raises critical questions: Which controls and product attributes must remain unchanged, and which can or must be adjusted to meet product quality criteria and business objectives? read more

  • Considerations When Qualifying a Supplier

    Ensuring the quality of finished products not only requires in-house quality control processes but also a robust supplier qualification process. Establishing a supplier qualification program is one of the most critical quality system activities for a manufacturer to reduce risks. read more

  • Zero Hour for Nitrosamine Compliance

    The FDA deadline to meet nitrosamine control guidance is upon us. Here’s a review of past nitrosamine-related regulatory actions — and lessons learned. read more
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