Through our “Validation Group”, comprised of engineers, chemists and technicians, Sphere has a major investment commitment to validation in all forms – information technology, manufacturing support technology, equipment, process, environment and testing.

Disciplined and thorough validation is at the core of pharmaceutical good manufacturing practice (GMP) and good laboratory practice (GLP). Sphere’s significant commitment to validation is another example of our total quality and compliance drive.

When any new manufacturing formula or method of preparation is adopted, steps are taken to demonstrate its suitability for routine processing. Through validation, using the materials, equipment and methods specified, a process must be scientifically proven to deliver a product of consistent and requisite quality.

Significant amendments to the manufacturing process, systems or environment, including any change in equipment, materials or methods are automatically subjected to Sphere’s strict validation & revalidation requirements.

Processes and procedures undergo periodic critical revalidation to ensure that they remain stable and capable of achieving the intended results.
Our commitment to validation, across the full gamut of our operations, is integral to our quality leadership strategy.

Please contact customer service for further information.