Quality Charter

cGMP manufacturing facility

 

Skyepharma complies with the current cGMP manufacturing requirements and puts priority on quality of its products. We are certified ANSM, FDA, Korean MSDS and ANVISA.

 

Strong internal quality process to meet cGMP standards

Scope of internal quality system processes

  • Production,
  • Process validation in manufacturing,
  • Conditioning / Packaging,
  • Analytical methods,
  • Cleaning,
  • Data integrity,
  • Control of documentation and records for full traceability.

 

Operational excellence program focused on “Right First Time” approach

This translates into a continuous development of the team’s expertise and a focus on key quality processes such as :

  • Deviation management,
  • CAPAs,
  • Change control,
  • Risk management,
  • handling of complaints,
  • Product release, etc.

We are able to meet our customers’ needs on time and to the expected level of quality

The Board of Directors is committed to continuously evaluate and improve the quality management system in place as well as the internal control systems by monitoring GMP operations.

We strive to exceed the highest quality control standards and best practices.

Skyepharma management strongly involved in cGMP manufacturing compliance

 

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
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