Validation

Method development and validation

Investigational research, changes in regulatory requirements and updating of dossiers are among the reasons that demand optimisation of analytical
methods. Our experienced staff can support you in the design of the development and validation protocol, determine the appropriate specifications,
perform the different stages of method development and validation and subsequently report the outcomes in a format that is acceptable to the
regulatory authorities.

Validation of pharmaceutical products
Every important change in the production process requires a new validation, resulting in many QC-samples and a strong increase of the workload of the
QC-laboratory. Thanks to our short cycle time and our flexible approach to customer demands, we have been a successful partner in many product
validations.
Water for pharmaceutical purposes, used in the production area or in the laboratories, is a predominant source of product or testing failures and
therefore water quality should be well controlled. PROXY is very experienced in the analytical control of pharmaceutical water, either according to the
European Pharmacopoeia or the United States Pharmacopoeia. In close collaboration with our clients we continuously monitor the water quality of
several production plants and analytical departments.

Cleaning validation
The carry-over of process residues from one production batch to another is becoming a high priority for regulatory authorities and health inspectors.
The design of a cost-effective cleaning validation implies many choices: which components are most hazardous, how many cleaning procedures are in place,
what are the high risk locations of the production equipment, which components can be detected to which level, how effective will sampling be, what are the
analytical costs per sample, etc. No surprise that cleaning validation is a distinct specialisation. PROXY has both the knowledge and the experience to help you in solving cleaning-related problems.