A regulatory inspection is a formal review conducted by national or regional authorities to assess whether pharmaceutical manufacturers, importers, or distributors comply with applicable laws, regulations, and standards, such as Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
These inspections may be planned routinely or triggered by specific concerns, applications, or reports of non-compliance. They involve examination of facilities, processes, records, and quality systems to ensure that medicines are consistently produced, stored, and distributed to the required quality standards. Regulatory inspections are a key tool to safeguard public health by verifying that companies meet their legal obligations and that patients have access to safe, effective, and high-quality medicines.
Regulatory Authority inspection per ICH-GCP E6(R3): 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 accessed at the investigator site, at the sponsor’s and/or service provider’s (including CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). Some aspects of the inspection may be conducted remotely.