cGMP Manufacturing
Saving lives with reliable, safe and compliant products.
cGMP (current Good Manufacturing Practice) is a comprehensive system of standards and practices that pharmaceutical and biotechnology companies must follow during the production and testing of their products.
The patient is at the forefront of everything we do
What is cGMP Manufacturing?
CGMP (Current Good Manufacturing Practices) manufacturing plays a pivotal role within the biopharmaceutical sector, constituting a regulatory framework endorsed by government agencies, such as the U.S. FDA, EMA or FIMEA. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. Notably, compliance with CGMP is obligatory, and regulatory approval is contingent upon its meticulous observance by manufacturers.
Source: U.S. FDA, 16/02/2024
Key principles of cGMP
Stringent Documentation
cGMP requires thorough documentation of all aspects of manufacturing, including processes, equipment, and procedures. This documentation serves as a clear record of actions taken during production, ensuring traceability in case of quality issues or recalls. If something was not documented, it was not done.
Qualified and trained personnel
The personnel component of CGMP emphasizes the importance of having qualified and trained staff to ensure product quality and safety. This includes hiring individuals with the necessary skills and experience, providing comprehensive training on relevant procedures and regulations, and implementing ongoing training programs to maintain competency. Additionally, CGMP requires proper hygiene and sanitation practices, such as wearing appropriate protective clothing, washing hands regularly, and following cleanroom protocols to minimize contamination risks.
Quality Management and Testing
Throughout the manufacturing process, accurate quality management measures and testing are conducted. This step is critical to promptly identify and rectify deviations from quality standards, ultimately guaranteeing that the final product meets safety and efficacy requirements.
Facility Design and Maintenance
Manufacturing facilities must be carefully designed and maintained to prevent contamination and provide optimal conditions for production. This ensures product integrity and safeguards the quality of biopharmaceuticals.
Validation
Validation is a cornerstone of cGMP, confirming that processes, equipment, and methods consistently produce desired results. This practice ensures the reliability and consistency of manufacturing processes and verifies that they are in control.
Our Process
1.
Solution Preparation
Solution preparation teams are to provide tailor-made solutions for cell cultivation, upstream, downstream and filling process use.
2.
Drug Substance
Our manufacturing process centers around the Drug Substance. These phases include carefully producing cells, efficiently generating viruses, and purifying the substance with great care.
3.
Drug Product
The Drug Product phase involves the final steps in the production of pharmaceuticals, where active pharmaceutical ingredients and other components are formulated into finished drug products that are ready for distribution and use.