When DB Lab is conducting an analysis of a material (typically a raw material) described in a monograph in one of the pharmacopoeias for the first time for at given customer, we have to verify that we can perform the analysis.
DB Lab has an SOP describing verification of pharmacopoeia methods. In that SOP, we have defined certain methods as 'simple' meaning we do not have to perform a special verification in order to conduct these methods, e.g. pH, total ash, melting point, and relative density.
Verifications are documented internally and described in a database. Raw data is stored together with data for the sample. Data can be reviewed on an audit.
For the analysis of a finished product, the method must be validated to the product in order to comply with the GMP rules. DB Lab performs validations according to ICH guidelines and customers’ wishes. Validations are documented with the protocol and report, where the customer is to co-sign the protocol.
A method received from a customer has to be validated at DB Lab.
If the method has already been validated somewhere else, and conditioned that DB Lab can see the validation report, DB Lab can perform a method transfer validation.
Few parameters from ICH guidelines are validated, e.g. specificity. Then (normally) 3 batches are analysed at the ceding laboratory and at the receiving laboratory (in this case DB Lab).
A method developed and validated at DB Lab can also be transferred to the laboratory of the customer.