The Analytical QC group performs product release and ICH compliant stability testing of GMP material using the qualified and / or validated methods indicated above.
An integral element of aseptic processing is the ability to monitor facilities and processes for microbial organisms. GBI has established procedures for evaluation of all GMP areas and processes to ensure continuous control. Sterility testing on all final vialed products is outsourced to a qualified independent safety testing lab to provide to our clients additional and objective assurance that their products have been manufactured and are safe in accordance with USP and CFR testing requirements.
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