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
The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified.Read More
As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project. The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle. A critical component for assuring stakeholder requirements are satisfied is following good engineering practice (GEP). While GEP is an expectation in the life sciences industries, the basic GEP elements required as a basis for GxP (good “anything” practice) quality guidelines and regulations compliance can, and should be, applied to all projects.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