Validation batches principles

Production
1

Before going to take a validation batches what principles we should follow

2

change control should be prepared.
validation protocol should be prepared.
updated Bmr should be prepared.
There should be a coordination bw Validation dpt, product development dpt n production dpt.

3

Also, 1. should be coordinated to QC regarding the sampling & testing plan.
2. Check availability and accuracy of all Analytical docs.
3. Identify all CPP and mention in protocol
4. Check availability and review of Raw materials , equipment-qualification, calibration, and its status

Thanks

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