Regulation and Quality Assurance of Cell Banks of Animal Cell Substrates

Quality Assurance (QA) and Compliance for cell line engineering

AmplyCell has its own quality department and SOPs guaranteeing high and constantly improved standards.

 

Moreover, we are constantly confronted with regulatory requirements related to such key issues as:

  • traceability
  • contamination
  • cross-contamination
  • (lab) facility management
  • staff training
  • management of non-conformities and out-of-line situations

Traceability management relates to cell line reception, storage, shipping, as it is for the raw materials used (ordering, receipt, storage and monitoring of expiry dates) and the supplier certification procedures.

 

To keep our instruments performing at top levels, all AmplyCell equipment is inventoried and each individual instrument is calibrated and maintained by external contractors.