Рет қаралды 977
#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 - kzfaq.info...
For detailed process validation - kzfaq.info...
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