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Life Science Training Institute > Resources > distribution
What Risk Factors Does The FDA Consider In Scheduling Drug GMP Inspections?

The FDA’s latest effort at transparency in the drug GMP inspection planning process can be found in the new Manual of Policies and Procedures (MAPP) 5014.1, “Understanding CDER’s Risk-Based Site Selection Model,” used to prioritize sites for routine surveillance GMP inspections.

Posted in:Manufacturing,
Tags:distribution,labeling,MAPP,packaging,risk,supply chain,
Too Little Or Too Late? Perspectives On FDA’s New Serialization Guidances

Looking forward, the U.S. pharmaceutical industry needs to be aware that despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.

Posted in:Manufacturing,
Tags:distribution,DSCSA,serialization,standardization,supply chain,
Serialization
State Of Serialization: Where FDA & The Pharma Industry Currently Stand

Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.

Posted in:FDA,Manufacturing,
Tags:distribution,DSCSA,identification,supply chain,
China
What China’s New Two-Invoices Policy Means For Pharmaceutical Manufacturers

Regulators in China have long been concerned that this multitiered network inflates drug prices. A 2017 pilot program, known as the “two-invoices” system, aims to address this issue by changing the way manufacturers, distributors, and healthcare facilities operate in the procurement process.

Posted in:Manufacturing,
Tags:distribution,distributor,drug,supply chain,

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