Smithers has announced that its facility dedicated to medical device testing services based in Shawbury, UK, is now compliant with current good manufacturing practices (cGMP).
Compliant
“Patient safety is a critical concern for all medical and pharmaceutical manufacturers, which is why the quality of the supply chain — including testing services — is so important,” said Dr Chris Berry, manager, medical device physical testing, Smithers Pira. “To carry out testing compliant with cGMP our laboratories adhere to a strict quality assurance system which is implemented through standard operating procedures. A system of routine inspections ensures that our facilities are maintained in good condition, our testing equipment is routinely checked and calibrated, our testing procedures are repeatable and reproducible and that our employees are well-trained and knowledgeable in their field.”
Services now available at the facility that are cGMP compliant include design verification testing, stability studies, batch release and post market surveillance. This new capability of performing high-volume routine testing compliant with cGMP is the latest investment by Smithers to support global demand in the medical device space.