With the downturn of the economy since 2008 it has become vital to stimulate the economy with local solutions and increased manufacturing. This time is ripe for R&D facilities to move towards start up scale manufacturing. Pharmi-Med Ltd. are proud to offer R&D facilities or Start Ups a priority support service to ensure all requirements are met to launch them into full scale production. This could be facility/building commissioning from HVAC, Cleanroom, Utilities, Laboratory equipment, Test Method Validation, packaging equipment or process validation requirements. Before you begin to manufacture or at pilot stage we can support validation requirements.
At Pharmi Med Ltd. We have knowledge and experience of Design Control and can complete documentation from start through to finish or support as per 21 CFR part 820.30:
- DESIGN AND DEVELOPMENT PLANNING
- DESIGN INPUT
- DESIGN OUTPUT
- DESIGN REVIEW
- DESIGN HISTORY FILE (DHF)
- DESIGN CHANGES
- DESIGN TRANSFER
- DESIGN VALIDATION
- DESIGN VERIFICATION
This includes Design Verification, and Design Validation activities with a focus on Test Method Validation support.