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Pharmaceutical Guidelines

Hold Time Study Protocol

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:

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

Document No :
PG/HOLD/001

Product :
XXXXX Tablets

Page No : 2 of 4

5. Hold Time Study Flow Chart :

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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

Description, Water content, As per


Loss on drying, Assay,
Specification
Related substances, Particle
size distribution, Bulk and
tap density

3.

Lubricated
Blend

45 days

Initial
15 days
30 days
45 days

500 gm

Loss on drying, Particle size


distribution, Bulk and tap
density, Blend uniformity,
Microbial test

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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