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Document No :
PG/HOLD/001
Product :
XXXXX Tablets
Page No : 1 of 4
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:
To analyses the hold time study samples as per the approved protocol and report the
results.
Review of Protocol and report.
Production
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
Document No :
PG/HOLD/001
Product :
XXXXX Tablets
Page No : 2 of 4
info@pharmaguideline.com
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Pharmaceutical Guidelines
Hold Time Study Protocol
Document No :
PG/HOLD/001
Sr.
No.
Stage
Product :
XXXXX Tablets
Proposed Sampling
Fold Time frequency
Sample
Quantity
Page No : 3 of 4
Tests to be Preformed
Acceptance
Criteria
1.
Binder
8 hours
Initial
2 hours
5 hours
8 hours
800 ml
Appearance, Viscosity,
Microbial test
2.
Granules
45 days
Initial
15 days
30 days
45 days
800 gm
3.
Lubricated
Blend
45 days
Initial
15 days
30 days
45 days
500 gm
As per
Specification
4.
Core Tablets
90 days
Initial
30 days
45 days
60 days
90 days
2.0 kg
Description, Hardness,
Thickness, Friability,
Disintegration, Dissolution
Assay, Related substances,
Uniformity of dosage units,
Microbial test
As per
Specification
5.
Coating
Solution
72 hours
Initial
12 hours
24 hours
36 hours
48 hours
60 hours
72 hours
800 ml
Physical appearance,
As per
Sedimentation, pH, Specific Specification
gravity, Viscosity, microbial
test
6.
Coated
Tablets
90 days
Initial
30 days
45 days
60 days
90 days
2.0 kg
Description, Hardness,
As per
Thickness, Friability,
Specification
Disintegration, Dissolution
Assay, Related substances,
Uniformity of dosage units,
Moisture content, Microbial
test
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As per
Specification
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Pharmaceutical Guidelines
Hold Time Study Protocol
Document No :
PG/HOLD/001
Product :
XXXXX Tablets
Page No : 4 of 4
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:
S. No.
Stage
1.
Binder
2.
Granules
3.
Lubricated Blend
4.
Core Tablets
5.
Coating Solution
6.
Coated Tablets
1st Batch
B.No.
Date
2nd Batc h
B.No.
Date
3rd Batch
B.No.
Date
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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