Quality Control

GBI’s QC team oversees the entire development and manufacturing process, ensuring that the products released comply with specifications for drug substances and drug products, as well as qualifying or validating all bioanalytical transfer methods depending on the stage of the product.

QC performs environmental monitoring of cGMP areas per USP <1116>, ISO 14644-1 and 14698-1, and Annex 1 (European Union) guidance specifications.

Our QC group offers a variety of testing services, including:

  • Endotoxin testing per USP <85> either by Endosafe or gel clot
  • Bioburden and suitability test per USP <61>
  • Sterility testing of inprocess samples per USP <71>
  • Total Organic Carbon (TOC) of swaps and rinse samples to verify manufacturing equipment cleaning
  • Environmental monitoring of ISO-classified rooms
  • High purified water testing per USP monograph for WFI
  • Product release testing per FDA/ICH/EU guidelines
  • Stability studies
  • Assay qualification and validation
  • Compendial method verification
  • 100% visual inspection of all drug product containers

QC Testing Procedures

Because of how integral the ability to monitor facilities and processes for microbial organisms is to aseptic processing, GBI has procedures for evaluating all cGMP areas and processes to ensure continuous control.

We outsource sterility testing on all final vialed products to a qualified independent safety testing lab to give our clients additional, objective assurance that their products are safe and have been manufactured in accordance with USP and CFR testing requirements. We also manage additional extended characterization testing such as peptide mapping and mass spectrometry.

Quality Assurance

Every one of our departments involved in cGMP manufacturing maintains a quality program that meets that department’s specific needs. QA is responsible for review, approval, and control of the critical processing steps, component release, and documentation made in support of cGMP manufacturing.

They also oversee audit and review, approval and release, vendor audits, cGMP training, CAPA, and biopharmaceutical quality assurance consulting with the use of validated electronic systems ensuring compliance as needed.

By building on a foundation of proper planning, performance of appropriate tasks, timely assessment, and continuous improvement of our established processes, we can support you with proper QA management systems at every step.

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