2/8付のECA/GMP Newsが「Questions & Answers on Good Distribution Practices (GDP) - Part 1」と題する記事を掲載しています。
2020年10月にECA主催で開催されたライブオンライントレーニング「The GDP Compliance Manager」からの質疑応答の一部のようです。
記事内の質問を列記すると以下の通りです。
Question 1.1: What is seen as regular training in GDP; once per two years or a shorter timeframe?
Question 1.2: How should I review the training effectiveness? Qualitatively or quantitatively? Or by any other means?
Question 1.3: There are different types of wholesalers; for wholesalers with a warehouse it is clear that more training is needed per year. However, a commercial affiliate or trading entity only buys and sells the goods and outsources the warehouse and transport.
Question 1.4: The Responsible Person (RP) should ensure a training programme is in place and staff is trained. Can the training tasks be designated to the human resource department or should this be a part of the QA department?
Question 1.5: What would be the preferred content of qualification of the GDP trainer?
Question 1.6: What industry-standard training courses/certification are there for RPs that you can recommend?
Question 1.7: Activities to third parties - Are 3 to 5 GDP-related training courses per year then still needed?
Question 1.8: Are there requirements on training records for specific tasks (handling of deviations, change requests, complaints, release of product etc)?
Question 1.9: What are some examples of how to conduct the periodical assessment of the effectiveness of training?
Question 1.10: Regarding training effectiveness: is a knowledge check mandatory?
Question 1.11: Is it enough with a training plan for the QA team or does it need to be per employee?
あくまでEU圏内のEU-GDPをベースとした、トレーナーの見解であり当局の見解ではありませんが、ご参考まで。
タイトルにPart 1とあることから、いずれ続編が出て来るものと思います。
関係者および興味のある方は、下記URLのニュース記事をご参照ください。
https://www.gmp-compliance.org/gmp-news/questions-answers-on-good-distribution-practices-gdp-part-1
2020年10月にECA主催で開催されたライブオンライントレ
記事内の質問を列記すると以下の通りです。
Question 1.1: What is seen as regular training in GDP; once per two years or a shorter timeframe?
Question 1.2: How should I review the training effectiveness? Qualitatively or quantitatively? Or by any other means?
Question 1.3: There are different types of wholesalers; for wholesalers with a warehouse it is clear that more training is needed per year. However, a commercial affiliate or trading entity only buys and sells the goods and outsources the warehouse and transport.
Question 1.4: The Responsible Person (RP) should ensure a training programme is in place and staff is trained. Can the training tasks be designated to the human resource department or should this be a part of the QA department?
Question 1.5: What would be the preferred content of qualification of the GDP trainer?
Question 1.6: What industry-standard training courses/certification are there for RPs that you can recommend?
Question 1.7: Activities to third parties - Are 3 to 5 GDP-related training courses per year then still needed?
Question 1.8: Are there requirements on training records for specific tasks (handling of deviations, change requests, complaints, release of product etc)?
Question 1.9: What are some examples of how to conduct the periodical assessment of the effectiveness of training?
Question 1.10: Regarding training effectiveness: is a knowledge check mandatory?
Question 1.11: Is it enough with a training plan for the QA team or does it need to be per employee?
あくまでEU圏内のEU-GDPをベースとした、
タイトルにPart 1とあることから、いずれ続編が出て来るものと思います。
関係者および興味のある方は、下記URLのニュース記事をご参照
https://www.gmp-compliance.
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント