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.
Some facts
63
percent of parenteral drug recalls were due to particulate matter and critical defects
25
percent of particle recalls in parenteral drugs were glass
250
Product producers assisted with QA guidance provided by R. Cherris with Bridge Associates Consulting
515
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.
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…
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