28/29 September 2021
The British health authority MHRA has recently published a statement in its blog, which reports about insufficient measures to avoid cross contamination in multipurpose facilities. This was noticed in recent inspections, which were mainly carried out as remote inspections. The authority's inspectors are now being specially trained for this area. The focus is on sites that handle products with low HBELs. HBELs are Health Based Exposure Limits, also called PDE (Permitted Daily Exposure) values by the EMA. They indicate, taking into account the available toxicological and pharmacological data, the maximum amount of contamination that may be allowed in a derived product and are required for the calculation of the limits in cleaning validation. The MHRA also refers to the Q&A document PI 052/1 recently published by the PIC/S.
An essential aspect for the MHRA is that the determination of HBELs should only be performed by persons with sound toxicological knowledge and experience. According to the MHRA, this was not the case in many cases, as inspections had shown.
Furthermore, many companies do not perform their required risk assessment based on HBEL values. However, these must be used for the derivation of technical and organisational measures in Quality Risk Management. The MHRA also points out that Quality Risk Management is a team task.
The MHRA is also not satisfied with the use of the criterion "visually clean" as the sole criterion after completion of basic cleaning validation. Cases have been observed where this has been done, although reliable compliance with the HBEL based level cannot be visually detected, so the visual method is not sensible enough. The MHRA sees a great risk especially in manual cleaning processes.
The MHRA has taken regulatory measures at some companies based on these findings and is telling other companies: "don't be caught and reasses your controls".
The statement on cross contamination can be found in the MHRA blog entitled "Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance."