The Board of the Eurasian Economic Commission approved the Guidelines for Planning Pharmaceutical Inspections for Compliance with the Requirements of the Eurasian Economic Union's Good Manufacturing Practice based on risk assessment.

The Guidelines contain recommendations on determining the frequency, scope and intervals of conducting pharmaceutical inspections at sites manufacturing medicines based on risk assessment for each individual facility. They take into account internal factors related to the specifics of the manufacturing process and the danger of the medicines, as well as risks arising from violations of the Good Manufacturing Practice.

When applied, the document will allow pharmaceutical inspectors of the EAEU Member States to optimize their resource plans for implementing the annual inspection plan (schedule), as well as will keep the approach to recognizing the results of inspections regardless of their intervals as enshrined in the Union's law.

The application of the risk-based approach will allow pharma manufacturers to optimize processes and ensure stable and reliable medicine manufacture through lowering risk. This will also enable saving financial resources related to receiving inspection teams.