In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s Good Manufacturing Practice (GMP) inspections. However, this Agreement was never fully implemented.Read More
Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this revision will have impact way beyond the EU borders.
World Health Organisation (WHO-all United Nations are members) and Pharmaceutical Inspection Co-operation Scheme (PICs) are actively involved in the update of Annex 1. The guidance is being developed with global harmonization of standards in mind.
Click below to view the full brochure on our understanding and capabilities surrounding the changes to come with this update:
Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management?Read More
Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the In Vitro Device Regulations.Read More