We interviewed an industry expert in the manufacture of cGMP medicinal products to understand what they would expect from a third party company before they would consider storing their material with them:
What if the needs of a product are complex or unique how can Cryoniss accommodate this?
We carry out rigorous Customer Onboarding, in which all new projects are triaged and as appropriate and checks and balances implemented to ensure ongoing compliance against the relevant regulations. For cGMP relevant material, bespoke quality control checks can be implemented and agreed in quality agreements or tailored product manuals. These procedures are created in collaboration with the customer and signed off by both parties to ensure satisfaction with processes and procedures.
For example: If the customer requires cGMP material to be segregated from other material for any reason, the level of required segregation must be determined during onboarding and this will then be written into the quality agreement /product manual / new SOPs as appropriate.
What sets you apart from other storage providers in your ability to store GMP products?
The Cryoniss team is made up of ex-scientists who understand the importance of sample integrity to the outcomes of experimental success. We have specific team members who have direct experience of working in companies that have produced GMP products, therefore the fundamental behaviours required to work to this stringent level of compliance are embedded within the foundations of our ways of working.
By achieving these objectives, our customers will be working with high quality reagents which are the keystone of any good experiment, and with our support with regulatory and logistics management tasks, they have more time to focus on developing their business.
Equally, Cryoniss supports researchers and pharmaceutical companies with GDP compliant storage and logistics management of medicinal products, including investigational medicinal products (IMP) for clinical trials.
Cryoniss works to the applicable principles of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice (GMP).
Samples are regulated by the Health and Safety Executive, Animal Plant and Health Agency and the Human Tissue Authority. Alongside these, Cryoniss adheres to regulations pertaining to The Medicines for Human Use (Clinical Trials) Regulations 2004 and European Medicines Agency reflection paper for laboratories carrying out clinical analysis.
Cryoniss is compliant with Good Distribution Practice (GDP) and holds a WDA(H) licence. To enable handling of medicinal products, Cryoniss complies with the EC guidelines for GDP of Medicinal Products for Human Use, Directive 2001/83/EC Community Code relating to Medicinal Products for Human Use and Regulations 43-45 of the Human Medicines Regulations 2012.
To enable handling of chemical compounds, Cryoniss complies with COSHH Regulations.