Quality Assurance
Meeting the authorities's requirements is one of the key points when evaluating the biosafety of medicinal products.
A product must be analysed at each development stage, depending on the regulatory body concerned.
Texcell makes particularly sure that it applies the latest guidelines published by the EMEA, FDA and ICH. We also work with a number of independent experts in biology, virology and immunology, who help draw up reports for submission to the authorities.
Moreover, Texcell’s own expert staff will readily help you present the data generated by the studies that we carry out on your behalf to the authorities.
Do not hesitate to ask us for further details on specific guidelines or regulatory requirements, according to your product and its development stage.
The main guidelines in use are as follows:
- Note for guidance on Quality of Biotechnological Products: derivation and characterisation of cell substrates used for production of biotechnological/biological products. (CPMP/ICH/294/95) ICH Topic Q 5 D, Step 4, Consensus Guideline, 16 July 1997.
- Note for guidance on Quality of Biotechnological Products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. (CPMP/ICH/295/95) ICH Topic Q 5 A, Step 4, Consensus Guideline, 4 March 1997.
- Points to consider in the characterization of cell lines used to produce biological. (CBER, FDA, May 1993).
- Points to consider in the manufacture and testing of monoclonal antibody products for human use. (59 FR39711). (CBER, FDA,1994) Revised. February 1997.
- Current European Pharmacopeia (6th edition)
- 9 CFR and 21 CFR (FDA, CDER)
