Glossary
Packaging
All the operations, including filling and labelling, by which a bulk product becomes a finished product.
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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During the inspection, our investigators observed unidentified white powder residue on non-dedicated product contact surfaces of (b)(4) used for packaging tablets that were held to be in “clean status.” Furthermore, your 2019…
FDA · FDA Warning Letter · 2023-09-12 -
Consequently, there is no assurance the outer packaging of materials and supplies will be adequately and routinely disinfected upon transfer from areas of lower air quality to areas of higher air quality.
FDA · FDA Warning Letter · 2022-09-13 -
FDA investigators observed that your firm lacked adequate quality unit (QU) oversight for the receipt of materials, repackaging, relabeling, and…
FDA · FDA Warning Letter · 2026-05-19
