What Patients Need to Know about Pharmaceutical Supply Chains—Chapters 2 & 3
Everything a critcal thinker needs to know about the supply chains for SARS-CoV-2 injections—packed with facts and evidence that can't be refuted.
PHARMACEUTICAL SUPPLY CHAIN BASICS
Distribution supply chains
Once produced and approved for sale, both small molecule and biologic drugs share the same distribution channel to market. Figure 1 shows a simple diagram.
Figure 1. Stages in distribution supply-chain for small and large-molecule (biologic) products
Both small-molecule and biologic products move through the distribution supply-chain. The wholesaler stores and moves finished products to pharmacies to be available for patient use.
Wholesalers are regulated in the same way manufacturers are, under Good Distribution Practice regulations.
Wholesalers purchase the products from the companies holding the marketing approvals.
From that point onwards, the license holders are no longer involved in the physical distribution, although they still have responsibility for pharmacovigilance (collecting reports of adverse events and acting on them where relevant) [but they are not doing it anymore].
Production supply chains
Figure 2 shows the stages involved in producing a small molecule drug. Some stages may be combined within the same facility. For example, intermediates may be produced as part of producing API.