Quality Systems

Nanophase is intensively focused on product quality, customers, and the Company’s total commitment to lean 6σ manufacturing and continuous improvement. With an internationally recognized quality system and operating its manufacturing facilities under FDA guidelines, Nanophase has a distinct competitive advantage as a leading manufacturer of engineered nanomaterials and nanomaterial solutions. Well-equipped Quality Assurance Laboratories assure outgoing product quality levels continually exceed customer expectations.

ISO 9000

The Company’s operations and facilities have been registered to the ISO 9001 international quality standard since 1997. The ISO 9001:2008 Quality Management System registration enables Nanophase to demonstrate commitment to service quality and customer satisfaction, as well as continuously improve the quality management systems and integration due to the realities of a changing world.

cGMP

Nanophase facilities conduct manufacturing operations under the FDA’s current Good Manufacturing Practices (cGMP). The Company is registered as a drug ingredient manufacturer and has been successfully inspected by the FDA. Key volume products manufactured for personal care are certified to the USP purity requirements.

GMP is designed to help assure the quality of drug products by ensuring several key attributes, including correctness and legibility of recorded manufacturing and control documentation. GMP also requires that all manufacturing and testing equipment be qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process be validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).

Download Nanophase Quality Policy.
Download Nanophase ISO 9001:2008 certificate.