Process Validation

Quality Assurance
1

We have planned three batches with varying weights: two batches of 105 kg and one batch of 80 kg. Although the weights differ, the manufacturing process remains identical for all batches.
Since the process parameters and conditions are the same for all batches, regardless of weight, we have decided to perform process validation only for the 105 kg batches.

Is this approach acceptable?

2

Please clarify your statement as it is confusing.
Please let us know, if you have planned process validation of 105 Kg of three batches OR two batches of 105 kg each and 1 batch of 80 Kg?

3

we have current order 105 kg two batch and 80 kg one batch now we dont know about next order.

4

Please confirm the following aspects,

  • For both the batch sizes (105 & 80 Kg) are the production equipment same and with same capacity?
  • Are the processing and Quality parameters (including Critical process parameters & Critical Quality Attributes such as mixing time, drying time, centrifugation time, milling time, and In-process checks) the same?
  • Identify the differences and evaluate for above.
  • Have you done process optimization for both the batch sizes to establish the above parameters?
  • Are you changing the batch sizes to match the ordered quantity? (As per your above statement)
  • All the above factors will determine the strategy of process validation.
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