Standard Operating Procedures (SOP) are common documents that outline step-by-step processes to achieve overall results of a longer overall process. Even though it is not a requirement from the DSCSA to have a product tracing SOP, we have noticed that during a few audits, most auditors are requesting for one. We decided to create a simple Product Tracing SOP for you to build upon.
Feel free to download it here:
TrackTraceRx-sop-template-word