2/2付のGMP Verlagが「TOP 15 Countdown: "Question of the Week"」と題する記事を掲載しています。
彼らは、"Question of the Week"と称した質疑応答を行っておりますが、昨年度のトップ15を列記しています。
以下の通りですが、かなり基礎的な内容であり、勉強になるかもしれません。
15. Which two factors are particularly important for a GMP-compliant process validation?
14. What does official calibration mean?
13. What are complexing agents and how do they work?
12. What is a risk?
11. How can medicinal products requiring cool transport conditions be transported?
10. In which phases is the quality risk management process divided?
9. What is a residual risk?
8. What is an alert limit, and what happens when it is exceeded?
7. What is meant by active and passive temperature control?
6. What are the requirements for successful quality risk management (QRM)?
5. For what purposes can drinking water be used in the pharmaceutical industry?
4. How do you ensure the traceability of the batch documentation?
3. What role does quality risk management play in the quality management system?
2. What data is monitored when monitoring a HVAC system?
1. Where can you find concrete information regarding "transport and temperature?"
興味のある方は、下記URLの記事をご参照ください。
https://www.gmp-publishing.com/content/en/gmp-news/gmp-newsletter/gmp-logfile-lead-article/d/1514/gmp-logfile-04-2021-top-15-countdown
彼らは、"Question of the Week"と称した質疑応答を行っておりますが、昨年度のトップ
以下の通りですが、かなり基礎的な内容であり、
15. Which two factors are particularly important for a GMP-compliant process validation?
14. What does official calibration mean?
13. What are complexing agents and how do they work?
12. What is a risk?
11. How can medicinal products requiring cool transport conditions be transported?
10. In which phases is the quality risk management process divided?
9. What is a residual risk?
8. What is an alert limit, and what happens when it is exceeded?
7. What is meant by active and passive temperature control?
6. What are the requirements for successful quality risk management (QRM)?
5. For what purposes can drinking water be used in the pharmaceutical industry?
4. How do you ensure the traceability of the batch documentation?
3. What role does quality risk management play in the quality management system?
2. What data is monitored when monitoring a HVAC system?
1. Where can you find concrete information regarding "transport and temperature?"
興味のある方は、下記URLの記事をご参照ください。
https://www.gmp-publishing.
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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
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