the stability study protocol.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the stability study protocols are generated and approved according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Designing the Stability Study Protocol

1. Stability study protocols must be designed based on the following factors:
   • Product type (aerosol formulations, including active ingredients, excipients, and propellants)
   • Packaging materials and their potential impact on the product’s stability
   • Storage conditions that reflect the expected use or distribution environment (e.g., temperature, humidity, light exposure)
   • Regulatory requirements for the product’s market (e.g., ICH guidelines, FDA standards)
   • Test methods and parameters for monitoring product performance (e.g., spray pattern, chemical stability, physical characteristics)
2. The protocol should clearly specify the storage conditions for each type of test, including:
   • Long-term testing conditions (e.g., 25°C ± 2°C, 60% ± 5% RH)
   • Accelerated testing conditions (e.g., 40°C ± 2°C, 75% ± 5% RH)
   • Intermediate testing conditions (e.g., 30°C ± 2°C, 65% ± 5% RH)
3. The protocol should also define the frequency and duration of sampling, for example:
   • Initial testing (at time 0)
   • Periodic testing (e.g., 3 months, 6 months, 12 months)
   • End-of-study testing (e.g., at 24 months or the intended shelf life)

5.2. Review of Test Parameters

1. The stability study protocol should outline all the test parameters to be monitored during the stability study, including:
   • Appearance (e.g., color, clarity, and can integrity)
   • Performance (e.g., spray rate, actuator functionality)
   • Chemical composition (e.g., active ingredient concentration, propellant concentration)
   • Physical properties (e.g., viscosity, pH, or any relevant physical tests)
   • Microbial testing (if applicable, to ensure the product remains microbiologically safe)
2. The stability study protocol should also specify the analytical methods and equipment to be used for each test parameter, including any validation requirements for analytical methods.
3. For photostability studies, the protocol should define the light exposure conditions (e.g., UV and visible light), and for stress testing, it should define exposure to extreme conditions (e.g., temperature, humidity, or chemical stress).

5.3. Protocol Approval

1. Once the stability study protocol is drafted, it should be reviewed by the QA team and regulatory affairs to ensure compliance with GMP and regulatory guidelines. The protocol should also be reviewed for feasibility and consistency with the product requirements.
2. After review, the stability study protocol must be approved by the QA team before stability testing begins. The approval should be documented, and the protocol should be signed and dated by the QA Manager and the Stability Testing Manager.
3. If changes are required to the protocol after approval, the modified protocol should be re-approved before any changes are implemented in the stability testing process.

5.4. Documentation and Record Keeping

1. All stability study protocols should be documented and stored in the appropriate format (electronic or paper) for future reference. The following documents should be maintained:
   • Stability Study Protocol (Annexure-1)
   • Approval Signatures (Annexure-2)
2. The stability study protocol should be reviewed periodically, especially if any changes in the formulation, packaging, or regulatory guidelines occur. Any revisions to the protocol should be documented and approved.

5.5. Protocol Revisions

1. If modifications or updates to the stability study protocol are necessary (e.g., due to new regulatory guidelines or changes in the product), the revised protocol must be prepared and approved by the QA team before being implemented.
2. Revisions should be documented in the Revision History section of the protocol, including the reasons for the change and the approval details.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• RH: Relative Humidity
• CFR: Code of Federal Regulations
• ICH: International Council for Harmonisation

7. Documents

1. Stability Study Protocol (Annexure-1)
2. Approval Signatures (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• International Council for Harmonisation (ICH) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Stability Study Protocol

Batch Number	Test Start Date	Test Duration	Test Conditions	Parameters to be Tested
Batch-001	10/02/2025	12 months	25°C/60% RH	Appearance, chemical composition, spray rate, pH

Annexure-2: Approval Signatures

Prepared By	Checked By	Approved By
Rajesh Patel	Anjali Sharma	Ravi Kumar
10/02/2025	10/02/2025	10/02/2025
Stability Testing Manager	QA Manager	Manufacturing Manager

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated stability protocol generation process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures