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Process Validation - Key Questions and Answers 1
#process #validation #ppq #process performance #interview #pharmaceutical
During this session, you will come to know the answers to the below questions. The answers are explained with reference to the different regulatory guidelines.
1. Is it mandatory that, the suppliers of critical raw and packaging materials should be qualified before manufacturing of validation batches?
2. During commercial process validation, is it required to compare, evaluate, and report the validation batch data with the Test /exhibit/submission batch data?
3. Can we follow the bracketing approach during process validation studies?
If you need further clarification guideline reference or further thoughts, please feel free to contact me.
For detailed Equipment/Instrument Qualification - https://youtube.com/live/jinEiaaJPEk?feature=share
For detailed process validation - https://youtube.com/live/_0NDBOVfjHk?feature=share
Subscribe - https://www.youtube.com/channel/UCrWoNI0Xsq0_2ZH3UZCXTMg?sub_confirmation=1
Join this channel to get access to perks:
https://www.youtube.com/channel/UCrWoNI0Xsq0_2ZH3UZCXTMg/join
Видео Process Validation - Key Questions and Answers 1 канала Hitendrakumar Shah
During this session, you will come to know the answers to the below questions. The answers are explained with reference to the different regulatory guidelines.
1. Is it mandatory that, the suppliers of critical raw and packaging materials should be qualified before manufacturing of validation batches?
2. During commercial process validation, is it required to compare, evaluate, and report the validation batch data with the Test /exhibit/submission batch data?
3. Can we follow the bracketing approach during process validation studies?
If you need further clarification guideline reference or further thoughts, please feel free to contact me.
For detailed Equipment/Instrument Qualification - https://youtube.com/live/jinEiaaJPEk?feature=share
For detailed process validation - https://youtube.com/live/_0NDBOVfjHk?feature=share
Subscribe - https://www.youtube.com/channel/UCrWoNI0Xsq0_2ZH3UZCXTMg?sub_confirmation=1
Join this channel to get access to perks:
https://www.youtube.com/channel/UCrWoNI0Xsq0_2ZH3UZCXTMg/join
Видео Process Validation - Key Questions and Answers 1 канала Hitendrakumar Shah
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8 ноября 2023 г. 19:30:08
00:13:23
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