Capsule: SOP for Conducting Long-Term Stability Studies for Capsules – V 2.0

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Standard Operating Procedure for Conducting Long-Term Stability Studies for Capsules

Department	Quality Control
SOP No.	SOP/QC/211/2025
Supersedes	SOP/QC/211/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for conducting long-term stability studies for capsules. These studies are crucial for assessing the shelf-life, potency, and quality of capsules over time under specified storage conditions.

2. Scope

This SOP applies to all long-term stability studies conducted on capsules at our facility. It includes the setup, monitoring, and evaluation of the stability of capsules under controlled environmental conditions over extended periods.

3. Responsibilities

Quality Control (QC) Team: Responsible for conducting stability studies, including the preparation, storage, and testing of capsules during the stability study period. The QC team will also document the results and ensure compliance with regulatory standards.
Production Team: Responsible for providing the necessary batches of capsules for stability testing and ensuring that the manufacturing processes comply with required standards.
Regulatory Affairs Team: Ensures that the stability study protocol and results are in compliance with regulatory requirements and guidelines.
Storage Facility Team: Responsible for maintaining the proper storage conditions for the capsules during the stability study period and ensuring that all conditions are monitored and recorded.

4. Accountability

The Quality Control Manager is accountable for ensuring the proper execution of the stability studies and the integrity of the data generated. The Production Manager is responsible for providing the required capsules for testing, and the Regulatory Affairs Manager ensures compliance with applicable regulatory guidelines.

5. Procedure

5.1 Pre-Study Preparation

Before initiating the stability study, ensure the following:

Define Study Parameters
1. Identify the capsules to be tested based on their batch number, formulation, and anticipated shelf-life.
2. Define the storage conditions for the study, including temperature, humidity, and light exposure, as per the stability study protocol.
3. Establish the sampling plan, including the time intervals at which samples will be tested (e.g., 0 months, 3 months, 6 months, 12 months, etc.).
Prepare Study Protocol
1. Prepare and approve the stability study protocol, which should include the study design, sampling methods, and testing procedures.
2. Ensure that the study protocol complies with ICH Q1A (R2) guidelines and any other relevant regulatory requirements.
Label and Identify Samples
1. Label all sample containers with necessary information, including batch number, date of manufacture, and the date of commencement of the stability study.
Prepare Storage Conditions
1. Ensure that the stability chambers are calibrated and that the environmental conditions (temperature, humidity, light) are maintained as specified in the study protocol.

5.2 Conducting the Stability Study

Follow these steps during the study:

Store Samples Under Controlled Conditions
1. Store the capsules in the stability chambers under the specified temperature, humidity, and light conditions.
2. Monitor and record the environmental conditions regularly to ensure that they remain within the specified limits.
Periodic Sampling
1. At each scheduled time point, remove a sample of capsules from the stability chamber for testing. Ensure that the sampling is done in a manner that avoids any contamination or alteration of the sample.
2. Document the date and time of sampling and the environmental conditions at the time of sampling.
Conduct Tests on Samples
1. Test the sampled capsules for relevant parameters such as potency, dissolution, disintegration, appearance, microbial contamination, and moisture content, as specified in the stability study protocol.
2. Record the results of all tests performed, including any deviations from the expected results.

5.3 Data Analysis and Reporting

After completing the study, ensure the following:

Evaluate Stability Data
1. Analyze the stability data to determine any changes in the capsules’ characteristics over time. This includes evaluating the changes in potency, dissolution, disintegration, and any other tested parameters.
2. Compare the results with the acceptance criteria defined in the study protocol to assess whether the capsules remain within the required quality specifications.
Prepare Stability Report
1. Prepare a detailed stability report summarizing the study results, including the data analysis, conclusions, and recommendations.
2. Include the data from all sampling time points and compare them with the stability specifications to determine the shelf-life of the capsules.
Review and Approval
1. The stability report should be reviewed by the Quality Control and Regulatory Affairs teams for compliance with GMP guidelines and regulatory requirements.
2. The report must be approved by the Quality Control Manager before it is submitted for regulatory filing or used in product release decisions.

5.4 Post-Study Actions

After the study is complete, ensure the following:

Archive Study Data
1. Ensure that all raw data, test results, and reports are archived according to the company’s data retention policy.
2. Maintain the stability study records for the required period, in compliance with regulatory requirements.
Review Study for Product Release
1. Review the stability data to determine if the capsule batch meets the required shelf-life criteria for product release.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
BPR: Batch Production Record
USP: United States Pharmacopeia

7. Documents

Annexure 1: Stability Study Protocol
Annexure 2: Stability Data Record
Annexure 3: Stability Report

8. References

USP <701> – Disintegration of Tablets and Capsules
International Council for Harmonisation (ICH) Q1A (R2) Stability Guidelines
Good Manufacturing Practice (GMP) 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

Study ID	Product Name	Batch Number	Start Date	End Date	Storage Conditions	Sampling Timepoints
SS-001	Capsule A	Batch 022	01/02/2025	01/02/2026	25°C, 60% RH	0, 3, 6, 12 months

Annexure 2: Stability Data Record

Batch ID	Test Date	Test Parameter	Initial Value	Final Value	Deviation
Batch 022	07/02/2025	Potency	98%	97%	None

Annexure 3: Stability Report

Batch ID	Final Test Date	Test Parameter	Result	Conclusions
Batch 022	01/02/2026	Potency	96%	Approved for release

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for long-term stability study	QA Head
01/02/2025	2.0	Updated test parameters and sampling schedule	Inclusion of additional tests for potency and dissolution	QA Head