Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

Take the Online Quiz on Part 11 and Read a Breakdown of Both “Elevens”

Vaisala

This article provides an overview of three focal points of both Annex 11 and 21 CFR Part 11, including: system controls, validation, and archiving.

Foaming via Melt Extrusion for Improving the Grindability of Extrudates and Dissolution Rate of Oral Dosages

G. Terife, C. Martin, and N. Ioannidis, Leistritz

Significant development efforts are occurring that utilize twin-screw extruder (TSE) technologies as part of unique foam extrusion systems for emerging bioplastics and pharmaceutical products.

Cleaning Validation for Pharmaceutical Manufacturing

Alconox

This paper outlines the basics of cleaning validation, as well as the kinds of support services needed for critical cleaning products in order to optimize your cleaning validation process.

Trends in Hand & Product Protection

Ansell

Joe Kubicek, president and general manager of the Ansell Single Use Global Business Unit, discusses changes in how today's pharmaceutical manufacturing and drug development companies approach their workers' PPE and safety needs.

Trends in Quality Agreements & Communications: A CMO Perspective

Milton Boyer, AMRI

As regulatory agencies increase focus on the relationship between the drug owner and contract provider, both parties must take responsibility for the relationship. This whitepaper examines this relationship and the cost of non-compliance.

Controlling the Physical Properties and Performance of Semi-Solid Formulations Through Excipient Selection

BASF

Semi-solid formulations are in a non-equilibrium state composed of numerous possible microstructures including API polymorphs, surfactant phases, crystalline lipophiles, polymer networks, and lipophile-surfactant gel or liquid crystalline phases. The selection of excipients in topical semisolid formulations can determine the structure of microscopic phases that form during processing. The influence of these phases on the formulation physical properties can be observed when measuring viscosity and observing microstructure. Exemplary data will demonstrate how specific excipients were used to modify formulation performance, and correct formulations that showed aqueous phase separation or weeping and improve stability.