Скачать или смотреть Process Validation - Key Questions and Answers 2

#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. In the Validation Master plan (VMP), do we need to specify developing acceptance criteria for qualification and validation activities?

2. During dissolution testing of the process validation batches, if the results comply with the specification, but are less than 100%, (for example – 85%) is it required to continue the test to evaluate the final drug release from the product?

3. The development report and/or a technology transfer document should be approved by the site quality only?
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?...
For detailed process validation - https://youtube.com/live/_0NDBOVfjHk?...
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