Finished product inspection is crucial for ensuring patient safety by confirming the packaging is intact and potentially harmful particulate matter are absent. At Selkirk Pharma, we perform 100% manual visual inspections using processes that comply with USP 790. We also have the necessary expertise to create our own Defect Kits in-house, which can help shorten project timelines.
Manual handling is considered the standard for visual inspection since it allows for physical manipulation of a vial to increase the detectability of any defects. By adopting this approach to finished product inspection, we ensure that products processed at Selkirk are essentially free of visible particulate matter in accordance with USP guidelines and requirements.
Our finished product inspection process for standard products (clear solutions in clear vials) involves visually inspecting 100% of samples manually, in accordance with the following USP 790 guidelines:
The initial visual inspection is followed by acceptable quality limit (AQL) sampling inspection, which entails randomized sampling throughout the batch with tighter limits, using a statistically robust sampling strategy. Any products outside of this range are entered into an established Threshold Study to provide a defect probability detection rate.
We also have robust processes in place for difficult-to-inspect (DTI) products, including products in amber vials and those with a tinted solution.
Defect Kits are essential to qualify personnel for product inspection. However, the timeline for creating a master set by a vendor takes 8-10 weeks on average. This can delay your product from reaching the patients who depend on it. Because we have the necessary skill set to create our own Defect Kits in-house, we can provide time savings of up to 50% compared to outsourcing. We have also developed a procedure for Defect Kit maintenance, meaning we can quickly re-create defects if they get damaged from use.