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- FAT, SAT를 반드시 해야 하나요?
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- 2019-05-16 오후 3:29:16
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- 4875
EU GMP Annex 15가 2015년 개정되었을 때에, 유럽 ECA가 대규모 컨퍼런스에서 개정된 Annex 15에 대한 설문조사를 한 자료가 있습니다.
2015년 9월 경에 실시한 설문조사에 따르면, 다음과 같습니다.
How do you assess the fact that FAT and SAT are only “could” option?
- 68.8 %: good idea the tests are only optional
- 18.8 %: consider these mandatory
- 10.4 %: not clear what it is about
- 2.1 %: not consider the tests to be necessary
동일한 주제에 대한 2018년 8월의 설문조사 결과는 다음과 같습니다.
"Are you using FAT/SAT as part of the equipment qualification?"
- FAT is used by 37% of the companies
- 55% sated "it depends on the complexity of the project
- 8% answered with No.
- SAT is used by 49% and comparable to FAT,
- 41% answered "it depends on the complexity of the project
- 9% answered with No.
이 조사의 아주 흥미로운 추가 질문은 이렇습니다.
Do you repeat tests you have done in FAT and/or SAT in IQ/OQ?
47% answered with Yes. Why is this so? The main reason is that they do so if transport or equipment installation could have an influence. But there were also answers like "QA department do not allow us to leverage the results", "Because the quality unit is not involved at FAT/SAT..." "it is a purchase process", "We perform specific tests for IQ and OQ"
두개의 설문조사의 기사글을 첨부하였으니 참고하시기 바랍니다.
2015년 9월 경에 실시한 설문조사에 따르면, 다음과 같습니다.
How do you assess the fact that FAT and SAT are only “could” option?
- 68.8 %: good idea the tests are only optional
- 18.8 %: consider these mandatory
- 10.4 %: not clear what it is about
- 2.1 %: not consider the tests to be necessary
동일한 주제에 대한 2018년 8월의 설문조사 결과는 다음과 같습니다.
"Are you using FAT/SAT as part of the equipment qualification?"
- FAT is used by 37% of the companies
- 55% sated "it depends on the complexity of the project
- 8% answered with No.
- SAT is used by 49% and comparable to FAT,
- 41% answered "it depends on the complexity of the project
- 9% answered with No.
이 조사의 아주 흥미로운 추가 질문은 이렇습니다.
Do you repeat tests you have done in FAT and/or SAT in IQ/OQ?
47% answered with Yes. Why is this so? The main reason is that they do so if transport or equipment installation could have an influence. But there were also answers like "QA department do not allow us to leverage the results", "Because the quality unit is not involved at FAT/SAT..." "it is a purchase process", "We perform specific tests for IQ and OQ"
두개의 설문조사의 기사글을 첨부하였으니 참고하시기 바랍니다.
