There’s growing pressure for drug manufacturers to have “end to end” visibility of their supply chains.
From the FDA’s Safety and Innovation Act — including the Good Importer Guidelines — to the Drug Supply Chain Security Act, FDA officials have squarely put the onus on manufacturers to stand behind the manufacturing of their products and the distribution of them into the market.
Read this white paper to learn about the challenges and implications of dealing with a global supply chain and the immediate need for drug makers to become more proactive. Other topics include:
- Views and requirements of worldwide regulatory bodies regarding end-to-end supply chain management
- Goals and deadlines of FDA, EMA and ICH regulations and guidance that will impact the management of raw materials and finished products
- Trends on supplier and distribution data you need to be aware of
- Proven strategies for effective risk management – how to measure corporate vs affiliate or site risk; what categories of risk you should be concentrating on and how to determine that concentration of risk
- Current best practices to build and maintain your supply chain (includes the downstream and upstream examples)