As large pharmaceutical companies outsource both ancillary services like analytical work, and even the full scale manufacture to specialist companies, we find ourselves working with both types of companies. Our support has included:
Method Development and Validation
Developing and validating methods “fit for purpose” to meet regulatory / investor needs. Our support in this area has included developing and validating procedures using XRD, XRF, ICP, GC, GC-MS, HPLC, UV, FTIR, Particle Sizing, Surface area, and many others.
We have a wide range of facilities available to meet ICH Conditions for R&D and Commercial product stability studies. Short term physical stability studies are a particular focus, supported by our XRD, TGA, DSC, particle size, Porosity / surface area. Our support can include the design of the stability study.
Regulatory focus on methods is increasing and there is a growing need for older methods to have additional evidence of validation and/or to be improved and revalidated. We have carried out a wide range of programmes in this area.
Cleaning Validation and Verification
We have good experience in developing Cleaning Validation/Verification methods and protocols and can advise and comment on the attendant swabbing procedures.
Raw Material Release Testing
Our experience in Method re-validation brought with it a wide range of raw material testing techniques which we continue to add to, our capabilities include the vast majority of Ph. Eur Raw material testing monograph procedures.
API Release Testing
These tests fall quite naturally from the method validation work above. We are particularly skilled in pulmonary product API testing, supported by our wide range of specialist equipment applicable in this area.