Can I prepare one common process Validation Protocol for 2 different batch size of same product & area

Quality Assurance
1

Can I prepare one common PVP for 2 different batch size of same product and area? Please give me answer with reason …

2

PVP is guidance document to execute Process validation study. you can design protocol in such way to covers all your requirements.

The study report must be different for both of the products. It must having different conclusions also.

You can give same reference of same protocol to both PV studies

Hope u understand

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3

According to my understanding, you can prepare one protocol of process validation of the same product if the following conditions are met,

  • The set of all manufacturing equipment is the same for both batch sizes. (This means the working principles of all equipment are the same for both batch sizes).
  • The critical process parameters (CPP) and quality attributes are the same for both batch sizes.
    If the aspects are not ok, then there will be lot of confusion in designing a common protocol of PV.