Last week, I wrote about commissioned serial numbers and questioned whether getting only commission serial numbers from the CMO is sufficient. Before I can answer that question, let us first take a look at the life cycle of a serial number and the position of the commissioning event in the life cycle. When packaging serialized drug products, the line control systems follow a process to generate, print, and manage serial numbers. This process is carried out by the following activities:
Shipping is the last activity that takes place on the CMO side. For CMOs, the life cycle of serial numbers starts with provisioning and ends with shipping. Similarly to the CMO’s shipping event, the manufacturer receives the serialized inventory. The serial numbers then take on another life cycle as they move on from the manufacturer to downstream trading partners.
Manufacturers rather than CMOs are responsible for the quality, security, and efficacy of serialized drug products. To ensure regulatory compliance, one must understand the minimum requirement of the law from countries with existing serialization regulations. The following chart captures the specific key points of the law in the serial number life cycle.
For China, manufacturers are involved early on in the life cycle at the provision stage. The China Food and Drug Administration (CFDA) manages a centralized serialization database. Manufacturers receive serial number provisions directly from the CFDA. To ensure data accuracy and integrity, the CFDA requires all partners in the supply chain to scan in and scan out all serialized drug products, exchanging data on various points of the life cycle. For Turkey, Argentina, Korea, Brazil, and US, the manufacturers are responsible for serial number reporting at shipping. In the age of cheap data storage, one may ask for more data than it is necessary. Considering the data retention requirement from all the regulatory bodies, loading up on data is not a bad idea. Otherwise, it is wise to have data retention in the CMO contract to mitigate the risk of missing serialized data records in the future.