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 Sphere's uncompromising commitment to Quality Assurance and regulatory compliance is highlighted by our extraordinary investment in Quality Assurance and technical personnel along with related policies, procedures & supportive systems.
A substantial proportion of our total human resources investment is focused in the areas of: - Regulatory Affairs
- Quality Control testing
- Validation
- Compliance
- Training
- Stability
- Auditing
Sphere's testing processes are established to approved national and international standards and include:
- Sampling and testing of all starting materials
- In-process testing
- Finished product testing
- Stability testing
Our laboratories are managed by a GLP compliant advanced LIMs software package with further supportive documentary systems and archive materials. All manufacturing batch documents and laboratory results, along with samples of the raw materials and finished products, are retained well beyond the products' published shelf life. This comprehensive, integrated, approach to quality assurance management ensures that quality is built in to & throughout our total product and service offering.
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