News about GMP/cGMP

24.04.2020

British MHRA temporarily relaxes GMP regulation

In order to address the current exceptional circumstances, the UK regulatory authority MHRA has opted for a temporary flexibility on good manufacturing practice (GMP). The authority considers these steps necessary to meet the current  supply needs of medicines in the UK. In this context, the GDP requirements for wholesalers have already been relaxed and the discretionary scope for QPs has also been extended.

These flexibilities should enable manufacturers to:

  • release additional quality system capacity for to focus on ensuring continuity of supply using quality risk management principles
  • address specific challenges created by international travel restrictions.

Pharmaceutical manufacturers, for example, may rely on the certificates of analysis from their suppliers if previous experience with the suppliers has shown that this is possible. The MHRA also allows companies to ship products from manufacturing sites under quarantine while quality control testing and batch certification is still ongoing. Under these circumstances, however, it must be ensured that access to the market only occurs once the product has been certified by a Qualified Person (QP). With respect to the pharmaceutical quality system, the MHRA currently allows supplier audits and investigations of minor events to be postponed to a later date. Internal audits and employee training may also be temporarily suspended.

All details about the increased flexibility in the areas of GMP, GDP and the tasks of the QP can be found here.


Source

MHRA: Exceptional GMP flexibilities for medicines manufacturers during the coronavirus outbreak

MHRA: Exceptional GDP flexibilities for medicines during the coronavirus outbreak

MHRA: Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus outbreak



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