The journey through the clinical trial pipeline is hardly ever direct. Obstacles will present themselves that may or may not have been anticipated. By doing your due diligence in selecting an appropriate outsourcing partner, some of the challenges can be turned into planned objectives as you move closer to (hopefully) positive results in the clinic. Pre-selecting a contract development and manufacturing organization (CDMO) based on not only capabilities but compatibility and trust will help throughout the journey.
Anyone with experience in the pharmaceutical industry knows that the APIs in drug products are tested rigorously for safety and efficacy before reaching the market. Before any raw material can be used for manufacturing, it must meet the requirements outlined in CFR chapter 211.84. Even minor issues with the API or a raw material could compromise the product’s integrity, leading to patient harm or expensive corrective actions such as recalls. Companies that perform drug product manufacturing and raw material testing take this responsibility seriously.
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.