Project Management & Validation
During the project validation & qualification, our specialized technicians develop protocols, calibrate, and validate according to ISO, FDA & EMEA GMP, GLP standards and national/international regulations.
Project Process
Process Supervision
Project management a critical element in building complex machinery for the pharmaceutical industries. Project manager, process engineers and designers are assigned to each project. They are involved earlier in the project to define or review the scope of work.
- Weekly project meetings
- Open communications
- Management of FAT & SAT tests
- Installation schedule
- Periodical quality inspection
- Health and safety management and monitoring.
Process Qualification
SPM has a highly qualified team of technicians experienced in qualification process DQ,IQ,OQ,PQ following the validation master plan and applying the highest standards: ISO, GMP and FDA.
- Validation master plan
- Standard Operating procedures
- Qualification of FAT & SAT tests
- Machine’s user manual
- Qualification documentation: IQ, OQ, PQ, FAT, SAT
Trial and Training
The last but not the least before we finish up the project is the production trail run and personnel training. SPM weight our responsibility as our reputation. SPM will accompany our customer to successfully produce three batch of product and provide throughout training program.