Meeting the Highest International Standards
Sphere Healthcare is committed to maintaining leading
standards of quality assurance.
Building quality into the product, Sphere Healthcare tests starting materials , in-process manufacture and finished products to stringent specifications. Finished product shelf life performance can then be studied in a formal stability program, where temperature & humidity controlled rooms meeting TGA and ICH requirements provide the capacity for large scale stability testing.
Supporting the ongoing integrity of Sphere Healthcare's operations are comprehensive validation, auditing and training programs. Validation protocols ensure plant equipment, manufacturing processes and analytical test methods deliver consistent outputs. Regular GMP training and auditing, including internal, external and supplier audits, ensure ongoing compliance throughout the quality system.
For more information please visit Quality Assurance.