This specialized service requires a high degree of technical expertise and the ability to interface with the company's skilled and professional staff.
Methods used in the evaluation of raw materials, in-process testing, stability indicating and finished product testing all require a careful, well developed plan for validation. DBT assists your company in assuring that the test methods used are appropriate, well designed and working as anticipated.
DBT provides the following services:
- Audit of existing laboratory facilities for compliance to the appropriate levels required by FDA.
- Development of method characterization procedures and review of existing method characterizations.
- Development of method validation procedures and review of existing method validations.
- Equipment qualifications
- Input regarding both USP compendial and non-compendial methods as applied to all aspects of the manufacture and release of product.
- Harmonization using principles of ICH as applied to method validation
- Development of Suitability for Use studies.
- Development of Method Transfer Studies.
- Test Method validation site training.