Quality and Compliance
Product quality is a fundamental part of our operational philosophy. OncoGenerix uses a risk based approach within a defined product life cycle methodology (ASTM E2500) for implementation, qualification, validation and operation of our facility.
The facility and process implementation, qualification, validation and revalidation are based on the following verification hierarchy:
The quality management system is based on the following documentation hierarchy:
OncoGenerix’s quality and compliance strategy is maintained by effective training and continuous improvements driven by feedback from quality observations.
Process development, process validation, supply chain, manufacturing operations and stability at OncoGenerix are supported by the quality control team. The team oversees:
- Test Method Development (USP, EP and CP).
- Test Method Validation.
- Manufacturing Support:
- Testing and release of API’s, materials and packaging components.
- In process control testing.
- Microbial control and monitoring.
- Utility and equipment monitoring.
- Container and closure integrity testing.
- Sterility testing.
- Release testing.
- Product and Formulation Support:
- Mixing uniformity studies.
- Stability Study Design.
- Stability Testing.
- Stability Storage.