Quality Control

Analytical Testing

In order to ensure product purity and integrity, extensive testing is required for each stage of the manufacturing process. GBI offers a panel of qualified assays readily available to expedite product and process development. GBI can also accommodate specific assays transferred from clients and can develop and qualify these assays in accordance with regulatory requirements. Assays that cannot be accommodated using GBI equipment or those that would not be compatible with GBI's facilities (such as viral testing) are contracted to qualified outside vendors.

Many types of pricing and services are available from run and report single analysis of an individual sample to complete assay validation in accordance with ICH guidelines.

Microbiological Testing

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. Bacteristasis and Fungistasis is determined the first time a product is analyzed to ensure valid measurement of sterility testing parameters.

Endotoxin is monitored for all buffers and equipment rinses and at defined stages for in- process and final product manufacturing. Total organic carbon (TOC) is also assessed for all water system points of use and equipment cleaning processes to ensure that the equipment and materials used are clean and free of all residues from previous products.