As a cGMP compliant CRO and in conformance with FDA guidelines and regulations, Blue Stream provides increasing rigor in method qualification and validation as a product moves toward late-stage clinical trials and on to commercial manufacture and release. Blue Stream provides ICH Validation Services to our clients for use in their Lot Release Programs.
Our ICH Validation Services comply with ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology.
The usual flow of activities at Blue Stream when conducting an ICH Validation program:
- Development or transfer of a method, yielding assay qualification data
- Sponsor approval of method SOP or Client Test Method (CTM)
- Laboratory Training (if not already conducted during method development activities)
- Validation Protocol drafted by Blue Stream
- Sponsor review, and mutual approval of Validation Protocol
- Execution of Validation Protocol
- Validation Report drafted by Blue Stream
- Sponsor review, and mutual approval of Validation Report
- SOP or CTM generation or revision
- ICH-Validated Method available for Lot Release Program
ICH Validation Services may be applied to, but not limited to, the following methods:
- Chromatographic Methods for Identity, Purity or Stability
- Immunoassay (ELISA) or other potency methods
- Spectroscopic methods to elucidate structure
- Electrophoretic methods for the determination of identity and purity
- Glycosylation or Sialylation methods if critical to product activity or efficacy
- Critical impurity assays
Blue Stream is well-equipped to be your complete Lot Release laboratory for both Drug Substance and Drug Product. We can provide data/report in a variety of formats, including issuing Certificate of Analysis (COA) for a full Lot Release program.