07.23.24 -- Getting The CAPA Framework Right The First Time

CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.

The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.

In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk.

Testing and selecting an aqueous cleaning system involves a seven-step process. In this chapter of The Aqueous Cleaning Handbook, we walk through those steps to help you optimize your cleaning process.

Enteric polymer coatings play a crucial role in oral drug formulations, protecting the API from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location.

Explore the evolution of Industry 4.0 in pharmaceutical manufacturing, the benefits and implications of Smart Factories, and the challenges along the road toward implementing a Smart Factory.

Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.

The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.

Review the case study and learn how one innovative technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

Conceived by the EPA more than 30 years ago, “green chemistry” prompts solutions to real-world environmental problems resulting from industrial processes, emissions, and waste.

Supplying a fiberboard mockup allows a customer to make additional considerations before finalizing the design needed to enclose several processes requiring product manipulation in two or more “phases.”

Quality by Design (QbD) achieves quality through an understanding of all components and processes, with a detailed understanding of risks and how they can be mitigated.

Understand an integrated drug substance and product CMC strategy for novel molecular formats and other recombinant proteins and tailored, product-specific solutions that enable acceleration to the clinic.