The Identifier System
Our data management system is designed for evaluating product defect issues along with providing training and guidance on particulate matter control, optimized inspection and 21CFR part 11 compliant electronic particulate and physical container/closure defect tracking systems. Focusing on Parenteral, Ophthalmic and medical device manufacturing to achieve a robust product lifecycle knowledge and control basis.
Visual Inspection Training
Watch the foreign particulate matter control stages training…
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Visual Inspection
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Some facts
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precent of 2018 parenteral drug recalls were due to particulate matter and critical defects
25
percent of particle recalls in parenteral drugs in 2018 were glass
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Product producers assisted with QA guidance provided by R. Cherris with Bridge Associates Consulting
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Visual Inspection and particulate control books sold co-authored by R.Cherris
Our solutions focus on sterile, parenteral and ophthalmic products
Parenteral product dosage forms continue to represent the majority of all US market recalls for product deficiencies detected by visual inspection.
Hospira Issues A Voluntary Nationwide Recall
On May 4th, 2021, Hospira—a Pfizer company, issued a voluntary nationwide recall to lot DN9185 for potential presence of visible particles. This drug product is…
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