In the pharmaceutical industry and in clinical research, Good Manufacturing Practice (GMP) is more than a set of rules - it is the basis for the confidence of patients, regulatory authorities and society as a whole in the safety of medical products. For facilities that cryopreserve biological samples for therapeutic purposes, this results in comprehensive requirements for every single element of cryostorage.
From the quality of the freezer used to the traceability of stored samples and the documentation of every single temperature deviation - GMP leaves no aspect unconsidered. For many laboratories, the question is not whether, but how they can make their cryogenic infrastructure GMP-compliant.
Consarctic® was founded with the mission to develop cryoproducts that not only meet but exceed these stringent requirements. In this article, we offer a comprehensive guide to GMP-compliant cryopreservation.
Every device that is used in a GMP-regulated process must be qualified. For cryogenics, this means
Consarctic® supplies the complete DQ, IQ and OQ documentation for all products - from controlled rate freezers to nitrogen tanks. Our certified technicians carry out on-site qualification and train your staff in correct operation.
It is not enough to have qualified equipment - the processes themselves must be validated. This includes:
The GMP maxim is: What is not documented has not taken place. This results in the following for cryopreservation:
All employees involved in cryopreservation must be demonstrably trained and the training must be regularly refreshed. Consarctic® offers comprehensive training programs for laboratory technicians and quality officers as part of its turnkey solutions.
Temperature mapping is a particularly critical aspect of GMP compliance. This involves verifying that the temperature inside a cryogenic container meets the specified criteria at all storage positions.
The eccentric opening of the Consarctic® BSD+ tanks helps to achieve a particularly homogeneous temperature distribution, as the heat input through the opening is minimized. This makes qualification considerably easier.
The software used in Consarctic® systems for control and monitoring fulfills the requirements for computerized systems according to Annex 11 of the EU GMP guidelines. These include:
Implementing a GMP-compliant cryogenic storage system requires careful planning and an investment in quality. But this investment pays off: It protects against regulatory complaints, product losses and - in the field of personalized medicine - against compromising patient safety.
Would you like to make your cryobank GMP-compliant or optimize existing processes? Contact our quality experts for a comprehensive consultation and find out how Consarctic® can support you on your way to full compliance.