Performed By / Verified By – A GMP operation in which one person performs a step in a production batch record and the execution of that step is observed and verified in real-time by a another person who did not perform the step.    

Why it Matters – GMP regulations require a second person to be present during critical steps of a production to visually confirm that each step was performed exactly as required by batch record instructions.  The use of trained verifiers help to ensure that errors are not made that could impact the quality of the product.

Case Study – A GMP manufacturing site was contracted by a client to produce active tablets for an upcoming clinical study.  The production commenced with one of technician weighing the active ingredient and each excipient (i.e., inactive ingredients that make up the formulation) and was followed by loading the materials into a v-shell blender.  Each of these steps were witness and verified by a second technician as being correctly performed.  The next step in the batch record called for transferring the blend to a roller compactor (i.e., equipment used to granulate the powders to aid in downstream processing).  The first technician used a plastic scoop multiple times to transfer the powder from the blender to the roller compactor.  The second technician entered his initials/date in the batch record’s verification field confirming that the transfer was performed correctly.   

Once this process was complete the first technician noticed that the plastic scoop was missing.  Both technicians searched the cleanroom but could not find the scoop.  Panicking, they inspected the compacted blend from the output-side of the roller compactor and found very small pieces of the plastic scoop.  Management was immediately notified of the issue.  The second technician (the verifier) was questioned by a member of the CMO’s Quality Department and revealed he did not actually observe the transfer of the blend to the roller compactor because he had left the cleanroom to find a logbook. 

Discovery how Eastlake Quality Consulting can improve your Quality Systems and training of employees to help prevent this problem from happening to you.