Project Description
December 2009 – May 2010
Solid Dosage Recipe Formulation System
| Organisation Function | GSK is a science-led global healthcare company providing healthcare products which can improve people’s health and well-being, ultimately helping them to live life to its fullest. |
| Project | Design and implement recipe driven active and excipient material checkweigh and dosing control system. Regulated by the Food and Drugs Administration. Compliant with FDA 21 CFR part 11 – Electronic Signatures and Electronic Records. Compliant with Good Automated Manufacturing Practices (GAMP5). |
| How we help | Requirements capture (URS), detailed design (Design Qualification), software development, simulated testing, factory testing, on-site commissioning, installation qualification, operation qualification and performance qualification. |