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:
This series of blog posts on CMO risk mitigation has been focused on the challenge of building an effective working relationship with the contractor a pharmaceutical company chooses to manufacture a drug. This third and final post in this series addresses the problem of bridging the gap from the laboratory to the manufacturing floor.
This post is the first in a series of three on the subject of CMO risk mitigation. Our focus will be to establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.
In these posts we will try to help managers evaluating contract manufacturing to:
-Determine how to work with the CMO to determine critical process parameters;
-Explore strategies to control or eliminate process variables; and
-Learn how to bridge the gap from lab scale to manufacturing scale
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.
Client Services is the front door where you and the vendor meet and work together to accomplish your specific service goals. The role of the Client Services team is to fully understand your requirements and then translate those into terms the rest of the organization can act on. If Client Services does their job effectively, they set the stage for achieving the desired results and an exceptional customer experience.
Here are four specific ways that a vendor’s Client Services approach can contribute to the success of your outsourcing experience:
Life sciences companies with complex warehousing and shipping requirements have a lot of questions – particularly when their requirements include temperature-controlled shipping. For a potential solution provider, it’s not enough just to have a refrigerated warehouse and trucks. The product may not even need refrigeration – it may need to be kept at or near room temperature. How can the pharmaceutical company identify a logistics vendor with the right competency? Here are five basic questions a pharmaceutical company operations manager can use to evaluate a vendor’s qualifications to provide a high-value solution:
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