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.
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.
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:
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.
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.
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.
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