Once the method is developed and optimized it can be validated, which is mandatory if the method will be potentially used for testing of a drug product. The implementation of a new method to the analytical laboratory is crucial in the method life cycle and is therefore under supervision of the laboratory management and quality assurance unit.
Validation is always conducted according to approved protocols which can be prepared either according to Selvita’s standard operating procedures (SOPs) or client’s SOPs. When the validation is complete, all results are described in the validation report which then should be approved by the client. The process of transferring a method from the company to another laboratory is also closely supervised. Transfers and validations of the methods are conducted in accordance with the current GMP regulations and approved protocols.
All the experiments required for these operations are conducted by our experienced analysts and supervised by the laboratory management. This guarantees that the analytical method works accurately and correctly in any workplace it is implemented.