STABILITY STUDY PROTOCOL

PRODUCT NAME EFFECTIVE DATE:

PROTOCOL NO. PAGE NO. 1 of 9

STABILITY STUDY PROTOCOL

PRODUCT:

PROTOCOL NUMBER:

REVISION NO.:

SOP/QA/040/F16.00
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1.0 APPROVAL:

The stability study protocol of [product name], has been prepared, checked, approved &
authorized by as following:

PREPARED BY SIGN/DATE

QA OFFICER

CHECKED BY SIGN/DATE

QC MANEGER

APPROVED & AUTHORISED BY SIGN/DATE

QA MANAGER

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2.0 TABLE OF CONTENT:

Sr. No. Content Page No.

1 Approval 2

2 Table of content 3

3 General Information 4

4 Objective of study 5

5 Responsibilities 5

6 Packaging and batch details 6

7 Test parameters and Specifications 6

8 Testing Schedule 7

9 Sample quantity 8

10 Test Procedure 9

11 Result 9

12 Deviation 9

13 Summary and Conclusion 9

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3. GENERAL INFORMATION:

1. Product Name :

2. Generic Name :

3. Dosage form :

4. Composition :

5. Licence No. :

6. Category :

7. BMR No. :

8. BPR. No. :

9. Batch Size :

10. Pack Description :

11. Storage condition :

12. Shelf life :

13. Reason for stability :

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4.0 OBJECTIVE OF STUDY:

To lay down the guideline to proceed with the Stability study of [Product Name] & to
describe the sampling points in the Stability study to establish that the product is stable for the
shelf life claimed on the pack at

5.0 RESPONSIBILITIES:

5.1 Quality Assurance:

• To prepare, review and approve stability protocol.
• Collect samples from packaging stage according to stability protocol.
• To charge samples in stability chamber at defined condition.
• To monitor the schedule and withdraw samples from stability chamber as per
testing station descripted in protocol.
• To review of stability report.
• Preparation and approval of stability summary sheet.
5.2 Quality Control:
• To review stability Protocol
• To analyse the samples as per specification and handover testing report and
raw data to QA Department.
• To initiate and jointly investigate with QA for any OOS and OOT observed
during analysis of sample at any testing station.

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6.0 PACKAGING AND BATCH DETAILS:

Batch No.
Standard Batch Size
Mfg. Date Expiry Date
Stability Condition 25°C ±2°/ 60% ± 5%RH and 40°C ± 2°C/75 % ± 5% RH
Primary Packing Material Details:
Name Item No. Source

API Details:
Name Item No. Source

7.0 TEST PARAMETERS AND SPECIFICATION:

Sr. No. Test Parameters Specification Limit

1 Description

2 pH

3 Assay

4 Impurity

5 Microbial limit

Test

6 Pathogens

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8.0 TESTING SCHEDULE:

8.1 Long term Study: Storage condition (25°C ±2°/ 60% ± 5%RH)

Tests 0 3 6 9 12 18 24 36

Description √ √ √ √ √ √ √ √

pH √ √ √ √ √ √ √ √

Impurity √ √ √ √ √ √ √ √

Assay √ √ √ √ √ √ √ √

Microbial limit Test √ √ √ √ √ √ √ √

Pathogens √ √ √ √ √ √ √ √

8.2 Accelerated Study: Storage condition (40°C ± 2°C/75 % ± 5% RH)

Tests 0 3 6

Description √ √ √

pH √ √ √

Impurity √ √ √

Assay √ √ √

Microbial limit Test √ √ √

Pathogens √ √ √

9.0 SAMPLE QUANTITY:

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Stability Sample Quantity

Interval
25°C ±2°/ 60% ± 5% (Long Term)
Chemical Micro
initial * *
3
6
9
12
18
24
36
Total Quantity: __ No. of sample

(*) - initial analysis done on finished product sample during batch release.

Stability Sample Quantity

Interval
40°C ±2°/ 75% ± 5% (Long Term)
Chemical Micro
initial * *

Total Quantity: ___ No. of Sample

(*) - initial analysis done on finished product sample during batch release.

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10.0 TEST PROCEDURE:

All tests shall be performed as per Specification at QC Lab or approved outsourced
Laboratory.

11.0 RESULT:
Results shall be summarized in Summary sheet of SOP on Stability study.

12.0 DEVIATION:
Any deviation observed during stability study shall be handled as per the current version of
Standard operating procedure.

13.0 SUMMARY & CONCULSION:

Mention the summary of findings and conclusion in report.

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