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
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
What is an appropriate level of GMPs for a supplier manufacturing site?Read More
In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going to get a drug into trials and eventually to the marketplace as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.Read More