ten23 health, a global contract development and manufacturing organization, today announced the successful implementation and certification of the ISO 9001:2015 Quality Management for its Development services in
Basel. This achievement underscores their unwavering commitment to delivering exceptional quality in the analytical and pharmaceutical development of sterile products.
ISO 9001:2015 is a globally recognized standard that sets out the criteria for a quality management system, focusing on enhancing customer satisfaction through the effective application of the system, including processes for continual improvement and assurance of conformity to customer, normative, and regulatory requirements. Using ISO 9001 helps ensure that customers get consistent, good-quality products and services.
The newly implemented Quality Management System and certification according to ISO 9001:2015 requirements, encompasses every facet of our analytical and pharmaceutical development processes for sterile dosage forms at ten23 health's BASE site in Basel. This includes development activities such as formulation development, analytical method development, primary packaging development, particle testing, container closure integrity (CCI) testing and the manufacture and testing of stability samples.
“We are extremely proud to have achieved ISO 9001:2015 certification for our Development Services,” said Hanns-Christian Mahler, CEO/Chief Enablement Officer of ten23 health, and continues: “This milestone reflects the diligence and dedication of our entire team in consistently delivering products and services that ensure Service and data quality and hence exceed the expectations of our clients and partners.”