Like the clinical gap assessment, the manufacturing gap assessment is an assessment of quality in the manufacturing space and is designed to identify gaps and put in place the solutions to address the gaps. The framework for conducting the manufacturing gap assessment is similar to the clinical gap assessment and comprises:
- Conducting interviews – with key stakeholders across the organization
- Review manufacturing documentation
- Synthesize into themes and trends, strengths, gaps
- Present gaps and recommendations to address gaps
The output of the manufacturing gap assessment will be a report showing gaps in the overall manufacturing processes and recommendations to address gaps. In our experience, specific recommendations from GMP gap might include for example development of SOPs and training, but the real focus tends to be in ensuring the vendor Quality Technical Agreements are comprehensive and in place.