The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is relaxing some GMP requirements to help manufacturers overcome challenges during the COVID-19 pandemic.
The agency said the temporary “flexibilities” are designed to keep the supply chain moving during the crisis.
Drug manufacturers have the option to put some GMP compliance steps on hold, including supplier audits, internal audits, GMP training and investigations of minor quality assurance failures.
Retesting of incoming raw materials can be limited to identification only, as long as the supplier provides a certificate of analysis, the agency said.
In addition, the MHRA will allow drugmakers to ship products while quality tests and batch certifications are underway, provided the products don’t enter the marketplace until they have been certified. — Tiffany Winters