Quality Assurance
All studies are designed and performed in compliance with the principles of Good Laboratory Practices (GLP). View our GLP certificate
For Batch release, we provide GMP (Good Manufacturing Pratices) studies. View our GMP certificate
Our Quality Assurance (QA) department is in charge of ensuring that GLP principles are complied with (as required) and that full traceability is maintained.
All our study documents (protocols, 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).
The QA department is the main point of contact for client or regulatory authority audits.
Most studies are designed and performed in compliance with the principles of Good Laboratory Practice (GLP). In 2002, Texcell obtained the highest quality level (grade A) awarded by the AFSSAPS (France's National Agency for Healthcare Product Safety).
Moreover, Texcell can perform studies in a GLP-like environment (i.e. not fully compliant with the GLP principles) or according to Good Manufacturing Practice (GMP) after client approval of the quality system.
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.
In 2006, the AFSSAPS acknowledged that Texcell is able to carry out GMP studies for the release of pharmaceuticals batches.
The QA department systematically inspects all studies carried out within the GLP environment. In concrete terms, this means that the QA team inspects the study protocol, critical phases, raw data and reports.
Moreover, QA staff inspect Texcell's own processes and conduct installation inspections.
On request, our clients can carry out audits in our laboratories. During validation studies (spiking experiments), sponsors can be present with full confidentiality.
All documents generated and exchanged during the study are kept in Texcell's secure archives for 3 years. After this period, archived data can be returned or destroyed, depending on the client's wishes.
