Implementing and operating an aseptic process is a complex activity integrating equipment and facility design, construction, commissioning, qualification and operation within a defined quality management system. However, there are other considerations important to implementing and operating an effective process to ensure the highest possible product quality, value and good customer relationships; these considerations are the cornerstone of the OncoGenerix Philosophy:
Quality & Compliance:
All OncoGenerix equipment, utility systems, facilities and documentation systems are designed and implemented to ensure compliance with the requirements of the SFDA (China), US FDA (United States) and European Medicines Agency.
OncoGenerix provide an empowered dedicated project manager to coordinate all activities on behalf of the customer on site. OncoGenerix does not offer a one size fits all solution, our services are focused on individual customer requirements.
To ensure compliance all site documents are in Chinese and English with English being the site language to ensure effective customer communication.
Total Integration of Services:
OncoGenerix takes a ‘process oriented’ systematic approach to aseptic processing to ensure quality documentation, compliance and total traceability from the first customer meeting to the shipping of the final product.
Quality of Equipment & Facilities:
OncoGenerix focus is to provide high quality reliable equipment and utility systems integrated within a facility of robust construction finished to high standards minimizing failures and unnecessary quality Photos People issues associated with poor equipment and utility system quality, facility construction and finishes.
The OncoGenerix site team is self sufficient and has all necessary skills to undertake equipment design, testing (including test method development, note book studies and engineering studies) qualification, maintenance and repair. The majority of the team was involved in the facility design, construction & qualification.
Flexibility & Scalability:
The OncoGenerix process is fully scalable from a batch of 5Ltrs to 500Ltrs allowing clinical product and commercial product to be manufactured in the same process. All filled product, no matter how small the batch, will meet the same quality, safety and regulatory compliance standards as commercially approved products.
Through our “Open Source” philosophy, information will be available to our customers, including:
- All customer product specific information associated with quality control and manufacturing
- All facility qualification information (VMP’s, media fill strategy, media fill data, etc.)
- Customer product specific SOPs
Diversity of Knowledge:
The OncoGenerix team has diverse subject matter expertise in all aspects of equipment and facility design, commissioning, qualification and operation. The team can effectively manage all events.
OncoGenerix is committed to the environment. Facility has an integrated waste management system and many design features to minimize energy usage.
OncoGenerix believes that all injuries are preventable and that all potential product exposures can be controlled. The OncoGenerix safety program is led from the top down with the management team being responsible and accountable.