Glossary
Authorized Person
The person recognised by the regulatory authority who is responsible for ensuring that each batch is manufactured and tested in accordance with the law and approved for release.
Related sections
WHO TRS 986 Annex 2, Part 1 의약품 제조 및 품질관리에 관한 규정 [별표 1]
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm also failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and…
FDA · FDA Warning Letter · 2023-09-05 -
Regarding your firm’s electronic documentation management system, you have acknowledged that previously system access and permissions allowed for unauthorized personnel to make changes.
FDA · FDA Warning Letter · 2024-05-21 -
For example, your QU failed to ensure there are adequate controls in place to assure that changes to CGMP records can be made only by authorized personnel, as employees…
FDA · FDA Warning Letter · 2024-06-18
