Validation Services
Our validation professionals and engineers can define your validation requirements, prepare protocols, execute the thermal and biological validation, data analysis and reporting of autoclaves (porous loads, fluid loads, laboratory and discard machines), ovens and tunnels, stability rooms and chambers (temperature and humidity), laboratory equipment (freezers to incubators) and shipping studies.
The Honeyman Group offers a variety of validation activities encompassing equipment qualification (laboratory, packaging and manufacturing), process validation (API, product and utilities), cleaning validation, shipping/transportation studies and re-validation/re-qualification exercises.
We have worked with a number of clients to implement a site wide risk based approach. Our experience in this area has delivered more efficient, cost-effective and improved validation by targeting critical control points within the manufacturing process. Tools such as HACCP and FMEA are applied under the ICH Q9 and ASTM 2500 framework.
Often performed to demanding time and production schedules we can either supply validation engineering equipment to clients wishing to carry out validation activities in-house or we can adapt our package of services to suit individual requirements by either implementing existing client procedures or delivering a full validation package including the development of a User Requirement Specification (URS), procedures, protocols and related documentation.
Typically involving on and off-site work, regular performance reviews and ongoing support to ensure Continuous Compliance Assurance (CCA), clients can be confident that their validated processes are in a continual state of inspection readiness.
Our validation skills stem from work carried out in the quality critical utility sector with significant expertise lying in the field of pharmaceuticals, medical devices and Healthcare. Specific services include:
- .Process Optimisation
- .Process Qualification
- .Process Monitoring
- .Thermal Mapping
For more information and for a quotation please contact us