Smithers has announced that its new UK-based 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 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.”
cGMP services now available at the new Shawbury facility include (but are not limited to):
- Design verification testing
- Stability studies
- Batch release
- Post market surveillance
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.
The laboratory team welcomes customers and prospective clients to visit the new facility and see first-hand how high volume routine medical tests are expedited.