European Union Grants a Good Manufacturing Practice Certificate to Nelson Laboratories
Nelson Laboratories today announced the successful receipt of the European Union's Good Manufacturing Practice (GMP) Compliance Certificate after the Medicines and Healthcare products Regulatory Agency (MHRA) inspection of the laboratory's facilities and processes.
"Manufacturers are obligated to defend their products and the supporting testing data," said Jeff Hone, vice president of quality at Nelson Laboratories. "The GMP certification for Nelson Laboratories satisfies the requirements of the testing laboratory quality system as set by the EU Commission. This certification will help expedite approval of products tested under our certified quality management systems."
The MHRA is an executive agency of the United Kingdom Department of Health and is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The MHRA, acting as an authorized representative of the EU, performs quality system inspections to assess the degree of conformity to prescribed relevant regulatory requirements of Good Manufacturing Practice established by EU compliance.
"Europe has established standards for handling new medical devices that are different from the FDA," added Hone. "Nelson Laboratories has been helping manufacturers get devices to market by staying current with both FDA and European trends and regulations. Now that Nelson Laboratories is certified in Europe, it will be even easier for sponsors interested in marketing devices there."