PDA Letter Article

Knowledge is Power

by Rafik H. Bishara, PhD, Eli Lilly and Company (retired) and Erik van Asselt, PhD, MSD

Reg Awareness Key to Supply Chain Success

The industry's ability to maintain a secure temperature-controlled supply chain continues to receive increased global attention from regulators, manufacturers and solution providers. The major goal in this endeavor is to ensure the proper handling, storage, and transportation of medicines until they reach the end user—the patient. Knowing the regulatory requirements and current best practices should be a top priority for all involved.


EU GMP Annex 16 requires companies to map their specific supply chains in order to determine the various partners involved as well as to assess the weakest links. This enables companies to improve their supply chains through risk analyses and mitigation measures. Risk management in the pharmaceutical supply chain encompasses quality risk management (QRM), data integrity, supply chain security, medicine verification systems and protection from theft, loss, tampering,, and diversion by employing multifaceted anti-counterfeiting measures.

Global regulations and quality standards covering GDP are also on the rise. Regulators want to see that patients are protected by ensuring that the quality, integrity, potency and efficacy of a medicine has not been compromised during its movement through the supply chain—from API to finished product. This is achieved through communication and knowledge transfer among regulatory agencies, manufacturers and distributors. The recent reciprocation between the U.S. FDA and EMA on regulatory inspections is one positive example of shared knowledge across the supply chain.

Serialization and security in the end-to-end supply chain will soon be a global regulatory requirement. This will cover manufacturers, packaging sites, wholesalers and third-party logistics. Aggregation at packaging sites, best practices in preventing counterfeiting, tampering, theft and mapping the pharmaceutical supply chain should also be addressed.

To learn more about effective temperature-controlled supply chains, consider attending PDA’s 2017 Pharmaceutical Cold & Supply Chain Logistics conference. Here, regulators, industry experts and solution providers will offer the latest case studies, advances and success stories. This conference has proven to be the ideal event to learn, debate and exchange ideas about how to safeguard a secure temperature-controlled supply chain.

Learn more about the 2017 Pharmaceutical Cold & Supply Chain Logistics conference.