The MHRA’s inspectorate and the Defective Medicines Report Centre (DMRC) are actively liaising with NHS and Specialist Pharmacy Services (SPS), following an increase in reports of Bacillus contamination in aseptic facilities. While no firm link has been identified between these …
This Blog relates to actions which licence holders should do following the issuing of USFDA Warning Letters. The MHRA’s Inspection Action Groups (IAG) are responsible for recommending and implementing regulatory action against companies for breaches across all GxPs, and its …
In March of this year, a letter was sent to Manufacturer’s “Specials” (MS) Licence holders who were involved in the manufacture of sterile products. An overview of unlicenced medicines guidance is provided here: Supply unlicensed medicinal products (specials) This was …
The purpose of this blog is to describe our approach to the validity date of UK issued certificates confirming compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Following the end of the COVID-19 public health emergency declared …
The world of GPvP is highly regulated, but the 2024 GPvP symposium showcased how regulation, collaboration and innovation can work together to enhance compliance, provide opportunities for better ways of working, and improve patient lives. The Symposium welcomed over five …
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 …
In March 2020 the MHRA Inspectorate published a blog post in which we announced that until further notice we would only conduct on-site inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk. In …
