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Latest Posts by Christelle Laot
January 7, 2015
Many regulations and initiatives worldwide aim at further securing and controlling the complex supply chain of healthcare shipments. The US Drug Supply Chain Security Act (DSCSA), also known as Title II of the Drug Quality and Security Act (DQSA), was signed into law on November 27th, 2013. It represents a staggered approach towards serialization, and electronic track-and-trace for human prescription drugs in finished dosage form.
January 8, 2014
This year the Food and Drug Administration (FDA) issued a report titled “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” (cGMP stands for Current Good Manufacturing Practices). The Medicines and Healthcare products Regulatory Agency (MHRA), the equivalent of the FDA in the United Kingdom, has long adopted a risk-based inspection strategy. A risk corresponds to the possibility that a function, a procedure or a product does not perform as expected. Risk management programs consist of activities and actions to control risks.
August 6, 2013
Healthcare shippers, including pharmaceutical, biotechnological, medical device, equipment and diagnostics companies carefully select their transportation providers. Obviously, pricing, reputation, reliability, expertise and infrastructure have always played an important role in selection decisions.