• Regulatory NewsRegulatory News

    ISPE: Global regulators discuss GMP deficiencies, data integrity, real-world evidence

    The COVID-19 public health emergency has prompted regulators to take a different approach to uncovering data integrity violations in virtual inspections compared to onsite inspections, said an official with Australia’s Therapeutic Goods Administration (TGA). The official also provided an update on the status of the EU’s good manufacturing practice (GMP) guide Annex 1, which addresses the manufacture of sterile medicinal products, at a 24 September panel discussion sponsore...
  • Regulatory NewsRegulatory News

    PIC/S looks to adopt EU Annex on qualified persons, batch release

    The Pharmaceutical Inspection Cooperation Scheme (PIC/S) this week announced plans to incorporate the EU good manufacturing practice (GMP) Annex 16 on batch release by a qualified person (QP) into a PIC/S guideline. The aim is to have non-EU/European Economic Area (EEA) members incorporate Annex 16 into their regulatory systems.   The EU’s Annex 16 covers the certification of a QP that can release product batches for marketing authorization holders in the EU or labeled...
  • Regulatory NewsRegulatory News

    European Commission Consults on Revised GMPs for Sterile Drugs

    The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...
  • Feature ArticlesFeature Articles

    Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation

    This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use. Int...
  • Health Canada Updates CGMP Guidance for Biologics and Blood Products

    Health Canada has updated its current good manufacturing practices (CGMP) guidelines for Schedule D (biological) drugs and human blood and blood components. The updated guidance covers 13 distinct areas of CGMP compliance: Premises : Sets recommendations for manufacturing facilities, including screening areas for blood donors, secured quarantine storage and handling areas, separate areas for testing biological samples and storage requirements. Equipment : Sets rec...