【精品】Pharmaceutical Industry Supply Chain Management66.ppt

Pharmaceutical Industry Supply Chain Management The Pharmaceutical Value Chain The pharmaceutical “value chain” is only partially synonymous with the pharmaceutical “supply chain” The “value chain” describes how the addition of knowledge to a specific molecule through transformational processes of RD, pre-clinical, clinical trial, manufacture, marketing and sales activities generates commercial value to a pharma/biotech company The “supply chain” refers to the activities involved with planning, sourcing, manufacturing and distributing your products as it does for any other company There is also a “clinical supply chain” which addresses sourcing and provision of materials to clinical trail investigators It’s still “Source”, “Make” and “Distribute” with “Plan” at the head of each major supply chain domain Pharma Supply Chain Considerations End-user (patient) safety Anti-counterfeiting requirements Product integrity Quality assurance Fraud prevention and detection Electronic signature requirements Records access and retention requirements Product tracking Class 2 pharmaceuticals must carry unique identifiers at the item level “Chain of custody” tracking from manufacturer to distributors and point-of-use (“pedigree” requirements) End-consumers are not the principal product customers CRM doesn’t focus on the patient (yet) Source - End-User Safety Considerations Foremost of all the considerations in the pharma supply chain Are the materials provided by our suppliers safe? Are the products manufactured by our company safe? Are all the products being manufactured reaching the distributors? Are any of our products being adulterated or counterfeited? The supply chain begins with the material supplied for product manufacture Key ingredients need to be covered by Supply Agreements Price, Source, Quantity, Quality, Delivery Quality Agreements Defined Specification Control, Change Control, Complain Resolution Pre-purchase Usability Tests Toxicity Requirements Know where