Quality Context provided development project management support and technical advice to a virtual pharmaceutical company wishing to develop a solid dose formulation with an Indian Contract Manufacturing Organisation.
We were tasked with:
- Providing technical guidance and troubleshooting advice for a tablet development project.
- Liaising with the client and the CMO on a regular basis to monitor project activities and keep the tasks on track with required timings.
- Ensuring that the development work and any associated validation protocols, validation reports, stability protocols and transportation studies were fully reviewed and approved for compliance with EU GMP and ICH requirements.
- A comprehensive project plan to ensure that key deliverables and project milestones were understood by all team members.
- Proactive technical project management, delivered via telecons, email communication and face to face meetings.
- A comprehensive audit trail of documentation to support development and validation activities, including detailed minutes of weekly project meetings.
- Attendance certificates for all trainees.
- Key project milestones for formulation development, analytical development and stability study set down were adhered to despite technical challenges encountered along the way.
- We received very positive feedback from the client in relation to both the technical advice offered and the manner in which the project was managed.
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