Manager of Medical Device Physical Testing
United KingdomContact Chris
Smithers new medical device testing facility now able to carry out high-volume routine testing compliant with current Good Manufacturing Practices (cGMP).
Smithers, world leader in rubber, plastics and composites testing and expert providers of chemical analysis, primary pack and shipment testing for medical devices, announced today that its new UK based dedicated facility for medical device testing services in Shawbury is now able to carry out high-volume routine testing compliant with current Good Manufacturing Practices (cGMP).
Compliance to cGMP involves the implementation of principles and guidelines which ensure that medicinal products and devices are consistently produced and controlled to suit their intended use.
“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.
“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.”
cGMP services now available at the new Shawbury facility include (but are not limited to):
Carrying out high-volume routine testing compliant with cGMP at the new facility is the latest investment by Smithers in support of global client demand within the medical device space. Already in 2017, the business added US based Extractables and Leachables Expert Dr. Daniel Norwood as Senior Consultant, announced the future opening of a North American extractables and leachables lab and made expansions in personnel and equipment to support migration chemistry studies at its Shawbury, UK analytical lab.
Find out more about our medical device testing.