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Raw Materials Are Not Fit For Use

These are some of the most dreaded words in Lifesciences. In this industry, manufacturers source many active ingredients, excipients, components, and in some instances raw materials from global suppliers to manufacture pharmaceutical products. Without proper due diligence, life sciences companies may wind up with a returned product that does not meet the necessary standards for quality. If the purchased raw materials do not meet the required quality and safety standards, there is a huge risk to patient safety that can lead to significant harm. The first step in applying any risk management process is understanding what a risk is. The term “Raw Material” is a general term, but it includes many different types of materials, including Active Pharmaceutical Ingredients (APIs), Critical Excipients, and Ancillary Materials.

Join us and we will outline:

  • Regulatory requirements for Raw Material Suppliers
  • Definitions of differ types of materials
  • Different risk attributes
  • How to consider risk attributes to manage suppliers using a risk-based approach

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