Handling Regulatory Inspections

Abstract

Abstract - As per the International Harmonization Guidelines (ICH) a regulatory inspection is the act by a regulatory authority (ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority (ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or CRO’s facilities, or at the other establishment deemed appropriate by the regulatory authority (ies). An inspection can happen at any time in any city or state. The mission is to protect consumers and enhance public health by maximizing compliance of regulated products and minimizing the risk associated with those policies. Inspections can cover finished human and veterinary drugs and biologics [9]. Key Terms - Board of Health (BoH), Inspections, Regulatory agencies