GLP/GCLP (Good Laboratory Practices/Good Clinical Laboratory Practices)
All studies are designed and performed in compliance with the principles of Good Laboratory Practices (GLP).
The Quality Assurance (QA) team is in charge of ensuring compliance with GLP principles are complied with (as required) and that full traceability is maintained.
All of our study documents (study plans, raw data and reports) are checked for quality. Internal audits are performed for critical steps and operating procedures (i.e. virus production procedures, assay methods, etc).
Good Manufacturing Practices (GMP)
For batch release, we provide GMP (Good Manufacturing Practices) studies.
Moreover, Texcell can perform studies according to GMP after client approval of the quality system. In 2006, the ANSM acknowledged that Texcell is able to carry out GMP studies for the release of pharmaceutical batches.
The QA department is the main point of contact for client audits or regulatory authority inspections.
The QA department systematically inspects all studies carried out within the GLP/GCLP/GMP. This means that the QA team inspects the study protocol, critical phases, raw data and reports. QA staff inspect Texcell’s own processes and conduct installation inspections.
In 2011, Texcell was inspected by the FDA; no observation was issued after 4 days of inspection.
All documents generated and exchanged during the study are kept in Texcell’s secure archives for 5 years. After this period, archived data can be kept, returned or destroyed, depending on the client’s wishes.
Our quality system is described by standard operating procedures, which can be consulted during audits. Do not hesitate to contact our QA department if you wish to carry out an audit.