International regulators launch sterile medicines inspection pilot

A two-year pilot programme for international collaboration in good manufacturing practice (GMP) inspections of manufacturers of sterile medicines has been announced.

Regulatory authorities from the European Union (EU), Untied States (US), United Kingdom (UK), Australia, Canada, Japan and the World Health Organisation (WHO) will co-operate to share information on GMP inspections of sterile medicine manufacturers which are based outside of these countries. They will also organise joint inspections of manufacturing sites of the highest identified risks.

The pilot programme will concern human medicines and certain biologics such as monoclonal antibodies and recombinant proteins, but exclude vaccines, cell and gene therapies, and plasma-derived products.

In this new pilot for sterile medicines, the participants are committing to:

  • coordinate inspection planning through risk-based approaches and share, in advance, their prospective inspection plans for the two years of the pilot with participating authorities;
  • conduct inspections in the manner described;
  • share information in English on inspection outcomes on a monthly basis;
  • provide inspection reports to other participants if requested.

Previous international collaboration in the Active Pharmaceutical Ingredients Inspection Programme has shown benefits in improving oversight of manufacturers worldwide, and has increased the efficiency of the utilisation of international inspection resources, allowing broader inspectional coverage and risk-based inspection planning. These programmes have been designed with a common goal of benefiting public health and patients who consume such medicines.

After the minimum two-year period, the pilot will be assessed by the participating regulatory authorities and the next steps in the collaboration will be identified.

To find out more about this new programme, click here.