Regulatory Open Forum

Hi,

Assuming we have a drug product with 10  different strengths, can bracketing be used for process validation? I know bracketing can  be used for stability but does it apply to validation as well?

If so what strategy should be used to select strengths that will be validated and consequently placed on stability?

Thank you

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Valeria Shkuratova
Canada
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Referring to the same topic. How about registration batches.

Would we have to produce 3 registration batches of each strength and place all of then on stability?

Thank  you

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Valeria Shkuratova
Canada
------------------------------

Original Message:
Sent: 17-Feb-2023 09:48
From: Valeria Shkuratova
Subject: Bracketing Validation Batches

Hi,

Assuming we have a drug product with 10  different strengths, can bracketing be used for process validation? I know bracketing can  be used for stability but does it apply to validation as well?

If so what strategy should be used to select strengths that will be validated and consequently placed on stability?

Thank you

------------------------------
Valeria Shkuratova
Canada
------------------------------

Bracketing approach is described in "Guideline on process validation for finished products - information and data to be provided in regulatory submissions", Guideline on process validation for finished products - information and data to be provided in regulatory submissions (europa.eu)

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Ajit Basrur
Worcester MA
United States
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Original Message:
Sent: 17-Feb-2023 15:02
From: Valeria Shkuratova
Subject: Bracketing Validation Batches

Referring to the same topic. How about registration batches.

Would we have to produce 3 registration batches of each strength and place all of then on stability?

Thank  you

------------------------------
Valeria Shkuratova
Canada

Original Message:
Sent: 17-Feb-2023 09:48
From: Valeria Shkuratova
Subject: Bracketing Validation Batches

Hi,

Assuming we have a drug product with 10  different strengths, can bracketing be used for process validation? I know bracketing can  be used for stability but does it apply to validation as well?

If so what strategy should be used to select strengths that will be validated and consequently placed on stability?

Thank you

------------------------------
Valeria Shkuratova
Canada
------------------------------

Depends on the market, and your strategy would depend on the type of product. For the "mature" agencies (FDA, HC, EMA) there should be no problem as long as your explain and justify your strategy.

We have successfully used bracketing for different fill volumes of a biological parenteral in the US at least. The main thing is to determine what aspects are different for the different strengths and the risks associated with those differences.

Some ROW countries have very specific requirements and bracketing can become more difficult. Though I've more often seen where bracketing for process validation was accepted but not for stability.

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Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 17-Feb-2023 09:48
From: Valeria Shkuratova
Subject: Bracketing Validation Batches

Hi,

Assuming we have a drug product with 10  different strengths, can bracketing be used for process validation? I know bracketing can  be used for stability but does it apply to validation as well?

If so what strategy should be used to select strengths that will be validated and consequently placed on stability?

Thank you

------------------------------
Valeria Shkuratova
Canada
------------------------------