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…
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Why is it important to have properly trained Visual Inspectors.
Having properly trained visual inspectors for parental 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…
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Transitioning from Vial to Prefilled Syringe
Ongoing advancement in technology, leads to increased development of parenteral drugs—one of the fastest growing choice for drug delivery in patients. Typically, manufacturing companies fill vials of products and ship them to physicians, pharmacies, etc. with an unfilled syringe; therefore, creating more work for all parties involved. Introducing prefilled syringes could cut manufacturing costs and…
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Starting your Sterile Injectables Program off on the Right Foot
Injectable drug products need to have an extreme and successful sterile fill to finish. How do you ensure your manufacturers obtain the highest level of operational and quality excellence? Manufacturing environments must be tightly controlled—especially due to the increase in demand of sterile injectables. Qualifying every part of the product leading up to the final…
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