Good manufacturing practice
Decentralised Manufacturing (DM) is the overarching term used in the UK to cover the two elements of the new manufacturing and supply framework: point of care (POC) and modular manufacturing (MM). A cross-agency team of Quality and Clinical Trial assessors, …
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 …
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 …
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 …
I write this blog post just after returning from the 2023 MHRA GMP Symposium in London. It has been more than two years since we held our last event virtually, and over three years since we were face-to-face for the …
GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licencing requirements and general handling of Investigational Medicinal Products (IMPs). …
Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what authorisations are required in order to manufacture within this sector of the pharmaceutical industry. For an overview of unlicensed Cannabis-Based Products for …
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 …
