Manual Visual Inspection is Still Critical

Automated visual inspection has been created to perform as an alternative to manual visual inspection.  This type of inspection is used to lower the cost and speed up the inspection process; pushing more drugs into the market.  In USP <1790> it explains that any inspection other than manual inspection has to be “equivalent or better performance when compared to manual visual inspection”.  Meaning, the automated visual inspection qualifications follow a relative criteria to manual inspection; but not absolute.

During the process, 100% of the units go through the automated visual inspection, then a certain percentage of these units are manually inspected to ensure statistics and purity of the automated inspection.

Manual visual inspection remains the most common form of visual inspection with parenteral drugs.  The PDA states that manual visual inspection is a critical procedure that all manufactures are required to perform—even if automated inspection is completed.  Manual data tracking is necessary during the inspection process to control proper detection of defects.

InQuest Science’s Identifier software helps manufactures keep track of all inspection data involving parenteral drugs.  This software will make the visual inspection process simpler and quick to locate data information and protect data integrity.  It follows USP <790> and <1790> of Visual Inspection of Injections. Calculating the criteria for success is the first step for inspector qualification.  With this testing, a group of inspectors need to perform the manual inspection multiple times—tracking all data found.  Detection rate should be as high as possible to ensure patient safety.  Visual inspection does not need to be 100% detection of critical defects, because that is nearly impossible.  Using InQuest Science’s Identifier Software, it can track the detection rates and if the product is outside of the allowed rate.

Read the full PDA article to learn more about the criticality of Manual Visual Inspection

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