Approach to Simplifying Aseptic Contract Manufacturing – Part 2: Documentation

Eric SmartIndustry, Innovation, Manufacturing

Aseptic manufacturing at Singota

In part two of the series, we focus on the impacts of the SA25’s operating principles, which combine to radically reduce and simplify manufacturing documentation. As we all know, the documentation requirements for cGMP manufacturing are extensive. Despite advances in automation and digital technology, the pharma industry has continued to rely heavily on legacy paper-based systems. Singota’s choice of the Vanrx SA25 Aseptic Filling Workcell was in part based on the way this system facilitates both the simplification and reduction in volume of batch documentation.

Raw Material Testing – Captisol

Trae CarrollIndustry, Testing

For the previous blog in this series, raw material testing programs were outlined, and common considerations for Contract Development and Manufacturing Organizations (CDMO) were discussed. In this section, the focus will be a specific example and highlight some of the thought processes behind raw material program development. Captisol®, a common formulation excipient for injectables, will serve as said example.

Microbiology Fulfills a Vital QC Role at a CDMO in Aseptic Filling and Sampling

Summer WadeIndustry, Manufacturing

When a pharmaceutical company is looking to outsource manufacturing and other services, in the background, the fundamental requirement is that the CDMO maintains an operating environment sufficiently controlled to formulate, manufacture, test, package, store, and ship products that will be for human use. Microbiologists play a vital role in ensuring conditions are optimal for the variety of pharmaceuticals that come into a CDMO.

The Internal Audit Process: How Your CDMO Keeps Tabs on Its Service Quality

DeAngelo TaborIndustry

When a pharmaceutical company engages a Contract Development and Manufacturing Organization (CDMO) to provide services, the most fundamental assumption is that the CDMO adheres to Good Manufacturing Practices (GMP). What entitles the CDMO to make that promise? The short answer is, it conducts regular audits of its own staff and business processes.

5 Stirring Stability Testing Facts

Tammy Thompson-MadsenIndustry, Testing

People who are not familiar with pharmaceutical development often express surprise and disappointment regarding the time and cost to bring new pharmaceuticals to market. Here are some interesting facts about stability testing: