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
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
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.
Particulates in Parenteral Products and the Search for the Holy Grail
Particulates in parenteral products as well as other pharmaceuticals have gained increased attention from regulatory agencies and from pharmaceutical firms who desire to be in…
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