病院薬剤部から見た医薬品異物混入問題の解析

• 松葉 和久

  名城大学薬学部

• 半谷 眞七子

  名城大学薬学部

• 長谷川 信策

  名古屋市立大学病院薬剤部

• 小池 香代

  名古屋市立大学病院薬剤部

書誌事項

タイトル別名

• Foreign Matter Issues from the Viewpoint of Hospital Pharmacy

抄録

  During 1987-1997, Nagoya City University Hospital experienced 22 cases of claim/complaint and recall of the pharmaceutical products. This included 9 cases of abnormality of container and package, 6 cases of contamination, 3 cases of content excess/shortage, and 2 cases of content abnormality and mislabeling. When observing from dosage form, a lot of complaint and recall were the injections of 9, and, next, the external preparations of 7. After enforcing PL law, claims/complains have increased in our hospital. We made the pharmaceutical companies claims of upgrading them and we got the improvement plans as the answer books of how these pharmaceutical companies resolved these problems as follows: contaminations of parts of manufacturing processes, insects, denatured ingredients etc. By using these answers from the companies, each reason of specific and interesting incident was observed and analyzed with the idea of Human Factors. As the results, reasons of most incidents were in the relationship between Liveware and Software.<br>

収録刊行物

• 日本PDA学術誌 GMPとバリデーション

  日本PDA学術誌 GMPとバリデーション 2 (1), 11-17, 2000

  一般社団法人日本PDA製薬学会

キーワード

• claim
• foreign matter
• GMP
• human factors
• incident
• recall

詳細情報

• CRID: 1390282679450036992
• NII論文ID: 130004851466
• DOI: 10.11347/pda.2.11
• ISSN: 18811728
• ISSN: 13444891
• 本文言語コード: ja
• データソース種別:
  • JaLC
  • CiNii Articles
• 抄録ライセンスフラグ: 使用不可