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
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
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.
5 Keys to Managing Information Technology in an FDA Regulated Industry
An IT career in the Life Sciences industry requires knowledge of regulatory requirements as well as having stringent controls and processes in place to ensure GxP requirements are met or exceeded. Here are some important items to address when managing information technology in an FDA regulated industry:
5 Takeaways from Preparing to Comply with the GDPR as a CDMO
What is GDPR? As a US based, small company, an EU law took some time to hear about. But once we did, we knew we needed to work on being compliant. Here are some lessons learned:
The Advantages of a Cross-Functional Staff Model in Pharmaceutical Manufacturing
As a CMO, Singota has chosen a cross-functional staffing model, spanning the functions of sampling/dispensing, formulation, filling, and finishing. Cross-functional staffing entails cross-training so that each employee can make the most of the skills they bring to the company, while acquiring new skills and perspectives.
Initial Considerations When Formulating Microparticle-Encapsulated Drugs
In part 1 of a 2 part blog series, we will explore some of the critical factors to consider when beginning work with these types of formulations.
The Internal Audit Process: How Your CDMO Keeps Tabs on Its Service Quality
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
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:
Hurry Up and Wait – The Complexities of International Shipping
When planning a cross country trip, it is important to carefully plan one’s route. When it comes to international shipping of pharmaceutical products, planning is equally, if not more, important. Delayed shipments could lead to compromised products and untreated patients.
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