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 Code of Federal Regulations Part 11, including:
  •   System Controls
  •   Validation
  •   Archiving

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

G. Terife, C. Martin, C. G. Gogos, 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.

Addressing Formulation Needs With A Different Technology: Say “Hello” to Ion Exchange Resins

Dow

Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Amie Gehris, technical service manager for Dow Pharma Solutions, will discuss the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.

Cleaning Validation for Pharmaceutical Manufacturing

Alconox

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