Recent patient safety disasters have focused attention on pharmaceutical excipients and APIs, resulting in new regulations that require closer control of the supply chain. Are drug manufacturers really "in control" of their ingredients suppliers? Are they working with third-party, certified auditors to verify whether suppliers meet standards? And, further down the supply chain, how are they controlling pre-formulation processes and the challenges of formulation? Are they working with process analytical technology (PAT) and quality by design (QbD) frameworks? What skill sets are they hiring? Where are they sourcing most of their ingredients?
These are some of the questions that we asked in CPhI/CPhI PharmaEvolution's first survey and report on this important topic. Experts in API, excipients, and QbD commented on the survey results, offering a snapshot of industry practices today ‒ and how they might be improved.Are you ahead of the curve, following the trend, or behind the curve, relative to your peers? Register to download this free report and find out.
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