Frequently asked questions
What is the main quality objective for advanced cannabinoids knowledge hub?
The objective is to define and maintain controls that ensure identity, consistency, safety and fitness for the intended use.
Which regulatory framework applies?
The applicable framework depends on jurisdiction, intended use, product classification and lifecycle stage. EU GMP, pharmacopoeial and product-specific requirements may all be relevant.
Is finished-product testing sufficient?
No. Testing is only one element of assurance. Supplier controls, process understanding, qualification, in-process monitoring and data governance are also required.
How should specifications be set?
Specifications should be scientifically justified using process capability, safety considerations, stability data, pharmacopoeial requirements and the intended clinical or technical use.
Why is trending important?
Trending can reveal gradual drift, supplier changes or method deterioration before individual results breach an acceptance limit.