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.
Chemical Safety Must Be Pervasive Across a CDMO’s Service Offerings
A CDMO for pharmaceutical companies will transport, store, test, process, fill, and package many different chemicals. Before a new chemical is brought into the facility, it is important to work closely with the client to evaluate the material from an environmental health and safety (EHS) perspective.
Chemical Safety Series
While finished drug products are intended for eventual human consumption, many of the raw materials and chemicals used to make these products require special safety considerations. Here are some tools to help CDMOs safely manage these important materials:
Transformation Check List – Growing into a CDMO
Even with an existing cGMP compliant organization and quality structure in place, bringing on a new service is a big job. Here are some checks to think about when expanding into a new service, specifically aseptic manufacturing:
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