Risk Assessment for On-Site Inspections
![ICH Q7 Auditor Training Course](files/eca/userImages/training.img/Z-ECA-ICH-Q7-Courses-2024-July.jpg)
Recommendation
3-5 July 2024
Vienna, Austria
Part of the ICH Q7 Training Courses 2024
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.
Related GMP News
19.06.2024More FDA Inspections again - also in the EU?
12.06.2024GMP Problems with critical Medicinal Products - what now?
15.05.2024Lack of Quality Oversight: EU Non-Compliance Report issued to Omeprazole Manufacturer
30.04.2024Chinese Anti-Espionage Law causes quite a Stir
17.04.2024Counter-Espionage Law: Do GMP inspectors no longer go to China?
27.03.2024EU Non-Compliance Report issued after insufficient CAPA