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SOP for Debarring Machine


Standard operating procedure to use the material collected from dedusting machine and use of residual recovery in the forth coming batches.

1.0 Purpose:

To lay down the procedure for the use of material collected from debarring machine.

2.0 Scope: 

This procedure is applicable to use of material collected from debarring machine in tablet department.

3.0 Responsibility:

3.1 Production:

3.1.1 To use the material collected from dedusting machine as per defined procedure

4.0 Accountability:

4.1 Quality Assurance:

4.1.1 To ensure the use of material from dedusting machine as per defined procedure.

5.0 Procedure:

5.1 Collect the powder from debarring machine in clean poly bag and label it suitably.
5.2 The collected powder of a particular batch can be used as residual recovery in the forth coming batches.
5.3 3-10 % (by weight) of the recovery from debaring machine should be added to the fresh batch in case of uncoated and film coated tablets.
5.4 3-5 % (by weight) of the recovery from debaring machine should be added to the fresh batch in case of enteric coated and modified release tablets.
5.5 The recovery has to be initially milled through 0.5 mm screen and then added to the fresh batch at premixing stage.

6.0 Abbreviation:

6.1 SOP- Standard Operating Procedure
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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