Validation Service

The engineers of the Glewdor company are certified experts in the field of “cold chain”. The experience of our specialists in the field of validation guarantees the implementation of each new project, of any degree of complexity. All work is carried out in accordance with the requirements of GDP, GSP, GMP, ISPA, ISPE, WHO (WHO) and the legislation of Ukraine.

We perform a full range of works with:

1. Validations of the client’s thermal containers: thermal containers, thermal boxes and thermal bags.
2. Validation (qualification) of pharmaceutical refrigerators, refrigerating chambers and refrigerating cabinets.
3. Validation (qualification) of pharmaceutical freezers, freezers and freezers.
4. Validation (qualification) of refrigerated trailers and semi-trailers with refrigerating equipment.
5. Validation (qualification) of the monitoring system of pharmaceutical warehouses, premises and chambers.
6. Validations (qualifications) of the cold chain – identification, analysis and recommendations for critical stages.
7. Validations (qualifications) of pharmacy and pharmaceutical compounds
– Checking of control bodies and emergency messages
– Creating a temperature map of the room
– Determination of critical points (points with the lowest and highest temperatures) for routine monitoring
– Checking the distribution and maintenance of temperature and humidity in empty and operated rooms
– Conclusions and recommendations regarding the operation of the premises.
8. Checking the functioning of the control bodies and indication of the ventilation, heating and cooling of warehouses; cold and freezer chambers, rooms, premises; refrigerators and freezers; combined refrigerating and freezing chambers in the medical, pharmaceutical, biotechnological and food industries.

Documentation provided:
Validation protocol (Validation protocol) is a document that describes:
– procedure of actions and tests to be performed during validation
– a list of specific parameters to be evaluated
– acceptable values of each of the parameters and evaluation criteria

Validation report (Validation report) is a document that describes
– results of the conducted validation;
– initial information about the object of validation;
– analysis of received data;
– proposals for re-inspection;
– conclusion.