Pharmaceutical Quality System
How quality is managed throughout pharmaceutical manufacturing.
Pharmaceutical manufacturing operations at SpectrumX are performed under applicable GMP requirements and within the site's Pharmaceutical Quality System.
Pharmaceutical Quality System
- Pharmaceutical manufacturing
- Quality control and assurance
- Validation
- Qualification
- Deviation and CAPA management
- Change control
- Supplier qualification
- Batch release/QP oversight as applicable
100% Visual Inspection
In-house visual inspection capability supporting terminally sterilised vial and ampoule manufacture.
Container Closure Integrity Testing
CCIT capability supports vial and ampoule presentations as part of SpectrumX's integrated sterile manufacturing infrastructure.
Environmental Monitoring
Grade C and Grade D cleanroom areas supported by controlled personnel and material flows, environmental monitoring and qualification programmes.
Looking for a Sterile Pharmaceutical Manufacturing Partner?
Whether you are developing a new product, transferring an existing programme, preparing for scale-up or looking for a long-term manufacturing partner, speak to SpectrumX about your requirements.