DBT provides an array of gap assessment services. Each is tailored to your needs. Assessments are conducted with an emphasis on interpersonal skill development and while simultaneous using the gap assessment as a training aide for company personnel. The gap assessments offered by DBT include:
- GMP gap assessments. These gap assessments help assess the level of regulatory compliance.
- Assessment of supplier/vendors regarding QA/QC systems appropriate for components, excipients and active pharma ingredients
- Assessment of cGMP implementation pursuant to ICH Q7A and FDA Compliance Program Guidance Manual 7356.002F.
- Technical gap assessments regarding product design, research, prototyping and laboratory testing. We pay particular attention to the validation of key analytical test methods as part of the gap assessment process of the quality system.
- Regulatory gap assessments conducted either before or after regulatory inspection with an eye towards corrective action determination and implementation.
DBT provides not only expert gap assessment service but as importantly can assist the company in the development, project tracking and implementation of Improvement Programs directed at corrective action implementation of systems upgrades.