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Quality Charter

Skyepharma is a One-Stop-Shop CDMO specialized in complex solid dosage forms, with expertise from early stage development to commercial manufacturing, including packaging and serialization.

From development to commercial production phases, Skyepharma complies with the current GMP requirements, and puts priority on quality of its products, processes and services. Through regulatory inspections, Skyepharma is certified by several health authorities (ANSM, FDA, KFDA and ANVISA).

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.

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
  • 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

 

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