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ten23 health is Successfully ISO 9001:2015 Certified

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Summation

  • 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.

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 the Company’s 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 analytical and pharmaceutical development processes for sterile dosage forms at the Company’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. “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.

“The certification serves as an affirmation of our commitment to quality, transparency, reliability, traceability and continuous improvement. By adhering to ISO 9001:2015 standards, we aim to ensure and enhance operational efficiency, ensure quality of services and hence customer satisfaction. This achievement not only strengthens our position as a reliable partner in pharmaceutical development but also underscores our determination to uphold the highest industry standards. Our BASE ® facility was previously implementing an electronic lab notebook system (eLN) for its Development Services, being a significant part of our quality standards.

“Our team’s expertise, combined with the rigor of our QMS, positions us to pioneer innovative solutions that drive positive impacts across the pharmaceutical landscape. At ten23 health®, we take immense pride in being a human-centric and sustainable strategic partner of choice for both the pharmaceutical industry and biotech start-ups. Our comprehensive service offerings encompass the entire spectrum of pharmaceutical product development and testing. From the initial stages of pharmaceutical product design, through the meticulous manufacturing process, to critical QC testing and stability assessments, we are committed to ensuring the highest standards of quality and safety. With our unwavering dedication to innovation and excellence, ten23 health® stands at the forefront of tomorrow’s medicines, shaping the future of healthcare.”

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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