1. A社は、異物が混入したオーラノフィンが、日本のGMPに合致し、且つ決められた品質に合致していれば、購入する意思はあった。
2. しかしながら、上記はB社が示した異物除去のプロセスで、必ず異物が除去される事を事前に証明し、且つその工程が日本のGMPに逸脱しない事を証明する事が条件となっている。
Rating
52
Translation / English
- Posted at 01 Nov 2019 at 16:27
1. A company intended to purchase in case auranofin with contamination matches Japanese GMP and required quality.
2. However, the above requires conditions that in the process of removing foreign materials which B company described, the foreign materials must be removed without error and it needs to be certified that the process won't deviate from Japanese GMP.
2. However, the above requires conditions that in the process of removing foreign materials which B company described, the foreign materials must be removed without error and it needs to be certified that the process won't deviate from Japanese GMP.
Rating
50
Translation / English
- Posted at 01 Nov 2019 at 16:29
1. A company had the intention to purchase if Auranofin that exogenous material is mixed meets with GMP of Japan and the fixed quality.
2. However, the above is the process of removing exogenous material shown by V company, and it should be under the condition that prove in advance the material inevitably be removed and do that the process is not deviated to Japan's GMP.
2. However, the above is the process of removing exogenous material shown by V company, and it should be under the condition that prove in advance the material inevitably be removed and do that the process is not deviated to Japan's GMP.
