Biopharmaceutical Quality Control
The Analytical QC group performs environmental monitoring and testing, product release and ICH compliant stability testing of GMP using qualified and / or validated methods.
An integral element of aseptic processing is the ability to monitor facilities and processes for microbial organisms. Goodwin 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 are safe and have been manufactured in accordance with USP and CFR testing requirements. Additional Characterization testing such as Peptide Mapping, Mass Spectrometry, are outsourced to external organizations.
Full Biopharmaceutical Quality Control Capabilities
The testing services offered by the QC group includes the following:
- Pharmaceutical microbiology
- Endotoxin by gel clot
- Bioburden and Bacteriostasis / Fungiostasis testing
- Total Organic Carbon (TOC)
- Environmental Monitoring of ISO classified rooms per ISO and USP Guidelines
- High Purified water testing per USP
- Product release testing per FDA/ICH/EU guidelines
- Stability Studies and adherence to ICH guidelines for Stability testing
- Qualification and Validation of Assays
- GMP Manufacturing support
- In-process testing
- Reference standard creation, characterization and qualification testing
- 100% visual testing of all drug product containers
An in process control system is in place by testing all the buffers and equipment rinses with an Endotoxin/Bioburden test. Total organic carbon (TOC) is also assessed for all equipment cleaning processes to ensure that the equipment used are clean and free of all residues from previous products.
The Quality Control lab is equipped with multiple High Performance Liquid Chromatography systems, a densitometer, plate washer and reader for ELISA testing, in vitro whole cell bioassays, capillary electrophoresis equipment and spectrophotometers.
Quality Control Solutions
Contact us to learn more about how Goodwin Biotechnology can provide Quality Control Solutions for your project.