QUALITY ASSURANCE, QUALITY CONTROL, QUALIFIED PERSON

GLP certificate

Physico-chemical testing (Category 1.)

Analytical and bioanalytical testing (Category 8.)

The certificate was first issued in 2014 and since that time FumoPrep Ltd. has been permanetly working in accordance with the principles of Good Laboratory Practice (GLP). The latest and currenty valid GLP license was issued in 2023.

This certificate also complies with the corresponding OECD/European Community requirements.

In a continuous pursuit of improvement, we conduct a self-inspection provided by an external expert twice a year.

All quality assurance documents are checked regularly and employees are trained frequently. Therefore we ensure we are always up to date regarding the regulations.

The training program covers:

• Documentation and archiving
• Workflow in the laboratory
• Sample handling and storage
• Requirements during analysis
• Equipment usage
• Audit and self-inspection
• Qualification and validation
• Change control, OOS and deviation

Our quality assurance team and laboratory staff also take part in GLP training annually, which is supported by the National Institute of Pharmacy and Nutrition.

We are always looking for new challenges, so if you want to work with a meticulous and determined team, feel free to contact us.