Validating laboratory tests
Well Spring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids, semi-solids, and non-sterile liquids.Well Spring offers full-service contract c GMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.There are a lot of tests that need to be performed to establish method veracity and these should all be written in your protocol prior to actually conducting the tests.The list of tests likely includes a system suitability requirement, precision, intermediate precision, accuracy, linearity, limited detection, limited quantification, specificity and robustness.
When used without modification, validated EPs shall be verified, whilst non-standard methods, home brew methods, validated methods which have been modified or are being used outside their intended scope shall be validated before being introduced into clinical and laboratory practice.
In order to fulfil the above requirements, three different approaches were used for: (I) verification of EPs already in use in laboratory; (II) verification of newly introduced EPs; (III) validation of EPs.
For verification, at least two performance characteristics should be verified according to the intended use of specific EPs.
It's a validated method - but there’s no need to ensure that the lab is capable of performing that method.
There is a process that needs to be followed and in place, to ensure that the transferring lab can perform that test reliably and accurately.