Quality is a key priority and requires the participation and commitment of all departments, at each level within the company.
The cGMP rules and all other regulatory requirements are always respected in order to reach the highest quality of our productions and comply to the best standards ever.
Our quality system is fully documented, explained and well understood by all employees to be correctly implemented. Quality management ensures that our staff is continually trained, our equipments validated, maintained and sufficient to ensure production and storage in perfect conditions.
Quality Control and Quality Assurance departments evaluate the quality of the products but also the respect of the procedures and the conformity of premises and equipments:
The Quality Control department develops and validates In Process Control (IPC) methods, release tests and performs stability studies.
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Quality Assurance is responsible for ensuring GLP and cGMP compliance. The GxP requirements, quality management, documentation system and process controls are required to ensure safe and consistent products.
Discover our QA department know-how.
Our regulatory compliance team routinely conducts internal and external audits which guarantee that operations are in compliance with appropriate regulations, guidelines, internal policies and procedures for the manufacture and control of drugs and biologics.
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Download our brochures for biologics manufacturing.
For any question on Novasep's manufacturing services and equipment for biologics, please contact us.