Ian Jackson

Pilot GMP Single Inspection Program

Ian Jackson, 20 February 2024 - Good manufacturing practice

Launch of a pilot Single Inspection Program, a global approach to GMP inspections of third country manufacturers. Health Canada, the Therapeutic Goods Administration (TGA) and the Medicines & Healthcare products Regulatory Agency (MHRA), all members of the Pharmaceutical Inspection Co-operation Scheme …

GMP & GDP Certificates: Validity Period Extended

Ian Jackson, 11 December 2023 - Good distribution practice, Good manufacturing practice

Following the end of the COVID-19 public health emergency declared by WHO in May 2023[1], on-site GMP and GDP inspections were restarted after being postponed or carried out remotely during the pandemic.  A number of postponed inspections still need to …

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• DSUR Submissions and Fees are Changing from 1 June 2024
• Pharmacovigilance unravelled: highlights of the 2024 MHRA GPvP Symposium
• Pilot GMP Single Inspection Program
• MHRA Pharmacovigilance Symposium 2024
• Guidance updates on to how to notify the MHRA of changes to the PV System