Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance outlining temporary flexibilities in Good Manufacturing Practice (GMP) to maintain medicine supplies during the COVID-19 pandemic. This framework allows manufacturers and importers to focus resources on supply continuity by using quality risk management principles to address challenges like international travel restrictions. Key flexibilities include limiting raw material re-testing to identification only, shipping products under quarantine while testing is completed, and deferring 'minor' incident investigations. Additionally, companies may put supplier audits, internal inspections, and routine training on hold, and extend timelines for procedure reviews. Manufacturers must ensure a Qualified Person (QP) is involved in all decisions to implement these measures. Required actions include reporting the use of these flexibilities to the MHRA via email and documenting all postponed activities within the company quality system for correction after the pandemic. The MHRA will regularly review these decisions as the public health situation evolves to ensure they remain appropriate.