09.28.23 -- Abbott Broadens Access To Cutting-Edge Biosimilars In Key Emerging Markets

Nothing is risk-free; now more than ever, all sourcing options have pros and cons that we need to assess to find the best fit. In this first article of a two-part series, we share three compelling reasons to consider outsourcing, along with key considerations for each.

To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (cGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.

In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.

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