Brussels launches GMP review
Notably updating its rules on cross-contamination
The European Commission has launched a widespread review of the European Union’s (EU) guidelines on good manufacturing practice (GMP) for medicines, notably updating its rules on cross-contamination.
This includes refreshed guidance on premises and equipment, with reference to new complementary toxicological assessment advice. The same applies to the GMP rules on production, where ‘changes have been made…to improve the guidance on prevention of cross-contamination…’
Other changes have been made to the legal obligations of manufacturing authorisation holders to ensure active substances are produced following GMP, including on supply chain traceability.
As regards quality control, a new section is included on the technical transfer of testing methods. The new guidance also suggests that quality risk management principles should be applied when investigating quality defects and complaints and when deciding product recalls. Also the Commission has clarified expectations and responsibilities regarding the reporting of quality defects to supervisory authorities.
The Commission links these GMP rules to other guidance setting health-based exposure limits regarding chemicals when assessing risk in the manufacture of different medicinal products within shared facilities.
The Commission also said there is a need to emphasise ‘the cause(s) of quality defects/complaints…and that appropriate preventative actions are put in place’.
Comments on the guidance are invited by 18 July to: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu