Regulatory Open Forum

Annex 1 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products states:

39. High standards of personal hygiene and cleanliness are essential. Personnel involved in the manufacture of sterile preparations should be instructed to report any condition which may cause the shedding of abnormal numbers or types of contaminants; periodic health checks for such conditions are desirable. Actions to be taken about personnel who could be introducing undue microbiological hazard should be decided by a designated competent person.

Do folks have experience responding to the recommendation for "periodic health checks"? Is the language included in an SOP?

Thanks.

Hi fellow RAPS members,

Just to clarify, we manufacture parenterals for clients in the US. Some of these clients are submitting marketing applications to Europe or Asia, and these may trigger a request for information on our policy requiring periodic physical examinations for personnel engaged in sterile manufacturing. Has anyone had experience answering a request like this?

Thanks for your help.