Risk Assessment for On-Site Inspections

Recommendation

15-17 May 2024
Berlin, Germany

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

Due to the pandemic-related travel restrictions, supervising authorities are currently mostly carrying out so-called distant assessments. However, most inspectorates also carry out partial on-site inspections, sometimes even unannounced.

The PIC/S has now developed a "Covid-19 Risk Assessment for National Routine On-Site Inspections". This risk assessment is based on a FMEA (Failure Mode and Effects Analysis) and should be carried out during the planning phase of the inspection together with the company to be inspected.
 
Topics to be discussed and assessed include:

• Limitation of possible COVID-19 exposure for inspectors
• Clothing (e.g. it is recommended to take off jewellery and to wear waterproof shoes)
• Cleaning of the workplace and materials used
• National guidelines for face coverings
• General hygiene guidelines

But what about unannounced inspections?

If an unannounced inspection has to take place, an "individual bespoke risk assessment" should be carried out; the assessment suggested in the document  should then not be used.