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Good Laboratory Practice

On request, Oroxcell can perform GLP studies.

Our Quality Assurance (QA) department is in charge of ensuring that GLP principles are complied with and that full traceability is maintained.

All our study documents (protocols, raw data and reports) are checked for quality.

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.

All documents generated and exchanged during the study are kept in Oroxcell’s secure archives for the time asked by the Sponsor. After this period, archived data can be returned or destroyed, depending on the Sponsor’s wishes.

Moreover, QA staff inspect Oroxcell’s own processes and conduct installation inspections. 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. The QA department is the main point of contact for Sponsor audits or regulatory authority inspections.