BioOutsource — cGMP compliant biotesting
Assay Validation and Lot Release
Assay Validation is an essential feature of assays that are used for GMP compliant testing of medicines. The generally accepted guideline for the validation of assays has been the International Congress on Harmonisation (ICH) document Q2(R1), this has been enacted in guidelines by the FDA and EMEA. BioOutsource can advise on the most appropriate assay validation strategy for your assay.
The final stage in the assay lifecycle is lot release testing. BioOutsource offer fully GMP-compliant lot release testing, with appropriate levels of assay and Reference Standard trending. The typical turnaround times is 10 days from sample receipt to issuance of a certificate of analysis.
