We are able to meet our customers’ needs on time and to the expected level of quality
Skyepharma internal quality system processes govern production, process validation in manufacturing, packaging, analytical methods, cleaning, data integrity and control of documentation and records for full traceability.
The Skyepharma Operational Excellence Program focuses on a ‘right first time’ approach, with continuous development of team expertise and focus on key quality processes such as deviation management, CAPA, change control, risk management, handling of complaints, product release, etc.
The Board of Directors is committed to regularly evaluating and continuously improving the quality management system in place and the internal control systems providing oversight of GMP operations.
”We strive to exceed the highest quality control standards and best practices.”
Skyepharma management is strongly involved in :
Control of production and quality control processes :
- Know-how: continuous development of the team expertise
- Suitable and qualified equipment
- Process validation (manufacturing, analytical methods, cleaning)
- Data integrity best practices
Assurance of Quality :
- Quality by Design
- Operational Excellence Program driven on the floor by right first time approach
- Global risk management (incl. prevention of cross-contamination)
- Quality management and performance measures on key quality processes (deviation management, CAPA, change control, handling of complaints, product release…)
- Control of documentation and records: full traceability
- Continuous improvement process
- Supplier Integration to offer best value to customers
- Exceed customer expectations on Quality, Cost and timelines
- Transparency towards our regulators and our customers
- Regulatory support