Pharmaceutical Guidelines

Hold Time Study Protocol

Document No : Product :
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PG/HOLD/001 XXXXX Tablets

1. Purpose :

Hold time study is the determination of time period for which the product can be hold at a particular
stage & period during processing, under defined storage conditions. Such study will support the
maximum time period between various stages during the manufacturing of the product. This protocol
will provide the guideline to determine the hold time for different manufacturing stages of XXXXX
tablets.
2. Scope :

This Protocol provides the guidance for determination of time limitation up to which bulk can be
stored before taken for next processing stage up to which time it can be stored in stipulated storage
container at stipulated storage conditions.
3. Responsibility:

Quality Assurance To prepare protocol.

Review of protocol and report.
Sampling as per the approved protocol.
Conclude the result. And Approval of protocol and result.
Quality Control To analyses the hold time study samples as per the approved protocol and report the
results.
Review of Protocol and report.
Production To review the protocol and report.
4. Sampling and Sample Storage:
The hold time study for the product shall be carried out on three batches. The officer IPQA shall
collect the sample as per protocol during the manufacturing of the planned batches. The representative
sample product should be kept in respective quarantined area in manufacturing department in stainless
steel container at 25C.

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 Pharmaceutical Guidelines
Hold Time Study Protocol

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PG/HOLD/001 XXXXX Tablets

5. Hold Time Study Flow Chart :

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 Pharmaceutical Guidelines
Hold Time Study Protocol

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PG/HOLD/001 XXXXX Tablets

Sr. Stage Proposed Sampling Sample Tests to be Preformed Acceptance

No. Fold Time frequency Quantity Criteria
1. Binder 8 hours Initial 800 ml Appearance, Viscosity, As per
2 hours Microbial test Specification
5 hours
8 hours

2. Granules 45 days Initial 800 gm Description, Water content, As per

15 days Loss on drying, Assay, Specification
30 days Related substances, Particle
45 days size distribution, Bulk and
tap density
3. Lubricated 45 days Initial 500 gm Loss on drying, Particle size As per
Blend 15 days distribution, Bulk and tap Specification
30 days density, Blend uniformity,
45 days Microbial test

4. Core Tablets 90 days Initial 2.0 kg Description, Hardness, As per

30 days Thickness, Friability, Specification
45 days Disintegration, Dissolution
60 days Assay, Related substances,
90 days Uniformity of dosage units,
Microbial test
5. Coating 72 hours Initial 800 ml Physical appearance, As per
Solution 12 hours Sedimentation, pH, Specific Specification
24 hours gravity, Viscosity, microbial
36 hours test
48 hours
60 hours
72 hours

6. Coated 90 days Initial 2.0 kg Description, Hardness, As per

Tablets 30 days Thickness, Friability, Specification
45 days Disintegration, Dissolution
60 days Assay, Related substances,
90 days Uniformity of dosage units,
Moisture content, Microbial
test

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 Pharmaceutical Guidelines
Hold Time Study Protocol

Document No : Product :
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PG/HOLD/001 XXXXX Tablets

6. Acceptance Criteria:

The acceptance criteria for all the tests should be same as per the hold time study specification. Any
significant change in the result needs to be investigated and addressed properly.
7. Revalidation:

The hold time study shall be performed again in case of any major change in product specification.
8. Evaluation:

The maximum period at which the observation for all the specified tests are within the specification
limits shall be the acceptable hold time for the respective intermediate. Based on the generated
results, evaluation & conclusion to be made along with established hold time period.
9. Batch Details:

1st Batch 2nd Batc h 3rd Batch

S. No. Stage
B.No. Date B.No. Date B.No. Date

1. Binder
2. Granules
3. Lubricated Blend
4. Core Tablets
5. Coating Solution
6. Coated Tablets
10. Re port:

Results obtained from the analysis shall be attached in the form of report.

11. Conclusion:

_______________________________________________________________________
_________________________________________________________ ______________

12. Approval
Name & Designation Depart ment Signature Date
Prepared By
Checked By
Approved By

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