Good Manufacturing Practice (GMP) guidelines ensure that protein production processes meet the highest standards of safety, quality, and consistency for therapeutic use. MITH has established a GMP unit for the small-scale production (up to 30 L) of small biologicals in Pichia pastoris.
Quality Assurance
Ensuring compliance towards the applicable health and GMP regulations is mandatory to guarantee a qualitative and safe Active Pharmaceutical Ingredient (API) intended for Investigation Medicinal Products.
It is the role of the Quality Assurance Team to translate the different regulation requirements into the daily VDU activities, in such a way that all instructions are unambiguous, understandable for everyone and documented according to GDP in our records.
The QA team encourages a quality mindset in all levels of the VDU by providing the necessary trainings and knlowedge sharings.
Working in a small team has the advantage of acquiring the overall oversight of the production and build a good QMS to maintain control over the quality of the VDU activities, to apply a quality risk-based approach and to create the oppurtunity to re-direct when necessary.
The QA team is responsible for ensuring continous compliance of the VDU QMS to the GMP and the Sponsor requirements. The VDU QMS is an electronic system, containing all procedural documents, training, deviation and change control management, internal and external audits planning or any other QMS element and is under control of the QA team. As last step in the process a QA release is performed based on a QMS, batch and test records to evaluate the compliance of the API towards the GMP regulations and agreed specifications.
Quality Control
The Quality Control department implements procedures which ensure the protection of human subjects from research risk, reliability of the data, and thereby assuring internal consistency. Therefore, specifications, sampling instructions, test methods and other Quality Control procedures are implemented by the Quality Control department. When the facility is not able to perform a test in house, Quality Control monitors any contract analysts. For both in house and outsourced QC, the department ensures that all necessary testing is carried out and the associated records evaluated. To release a product produced in the VDU facilities, QC publishes a Certificate of Analysis including al test results and their specifications.
Next to the approval/rejection of bulk and finished products, the Quality Control department is also responsible for the approval/rejection of starting materials and packaging materials.
After the release of a product, the Quality Control department ensures the monitoring of the stability of the product based on predefined stability plans.
Quality Control testing is performed on qualified equipment (IQOQ, yearly calibrations) in a qualified environment using validated methods according to ICH-Q2 guidelines (accuracy, linearity, suitability,...).
Apart from QC samples, the Quality Control department oversees the control of the reference samples and retention/reserve samples of materials and products when applicable.
Finally, the Quality Control department participates in the investigation of complaints related to the quality of the product, etc. All these operations should be carried out in accordance with written procedures and, where necessary, recorded.