These flexibilities should enable manufacturers to:
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.
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