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:
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This brochure was written by John Henchion, Global Director of Quality, Compliance, & Regulatory services. John has more than 23 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. Have questions now? Email John at john.henchion@cagents.com