Blog Archive

Advantages of the InQuest Science Identifier Defect Management System over MES

by

The InQuest Science Identifier (ISI) defect management system offers several advantages over using larger Manufacturing Execution Systems (MES) for parenteral visual inspection test set management, training, and qualification of visual inspectors and vision systems. Specialized Expertise: The ISI defect management system is specifically designed by subject matter experts (SMEs) for pharmacopeial parenteral visual inspection, which requires … Read more

Why is it important to have properly trained Visual Inspectors.

by

Having properly trained visual inspectors for parenteral drugs is important because visual inspection is a critical step in ensuring the safety, efficacy, and quality of pharmaceutical products. Visual inspection involves examining the drug product visually to detect any defects, such as particulate matter, container defects, or other visible abnormalities that could affect the product’s quality … Read more

Removing Gaps in Data Integrity

by

Between January 2015 and May 2016 there was a total of 28 warning letters issued to pharmaceutical manufacturers. 21 of those letters were centered around issues involving data integrity.  If data is mutilated and changed, it does not promise that a product is safe, data integrity is extremely important to follow.  It is used to … Read more

Manual Visual Inspection is Still Critical

by

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 … Read more