Capsule: SOP for Photostability Testing of Capsules – V 2.0

Auditor

2 days ago

Standard Operating Procedure for Photostability Testing of Capsules

Department	Quality Control
SOP No.	SOP/QC/213/2025
Supersedes	SOP/QC/213/2022
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 photostability testing on capsules. Photostability testing assesses the stability of capsules when exposed to light to ensure their efficacy and safety under typical storage conditions.

2. Scope

This SOP applies to all photostability tests conducted on capsules at our facility. It includes the setup, exposure, monitoring, and testing of capsules under light exposure conditions.

3. Responsibilities

Quality Control (QC) Team: Responsible for conducting photostability tests, including sample preparation, light exposure, and testing of capsules during the study. The QC team also documents the results and ensures compliance with regulatory standards.
Regulatory Affairs Team: Ensures that the photostability study protocol and results comply with regulatory requirements and guidelines.
Storage Facility Team: Ensures that the light exposure chambers are set up and maintained with the correct light intensity and duration as per the study requirements.
Production Team: Provides the necessary batches of capsules for photostability testing and ensures that manufacturing processes meet required standards.

4. Accountability

The Quality Control Manager is accountable for ensuring that the photostability study is properly executed and that the data generated is accurate. The Regulatory Affairs Manager ensures compliance with regulatory guidelines. The Production Manager ensures that the required batches of capsules are provided and meet quality standards.

5. Procedure

5.1 Pre-Study Preparation

Before initiating the photostability study, ensure the following:

Define Study Parameters
1. Identify the capsules to be tested based on batch number, formulation, and anticipated shelf-life.
2. Determine the light exposure conditions, including light intensity (e.g., 1.2 million lux hours) and the type of light (e.g., UV or fluorescent) to be used for exposure.
3. Establish the sampling schedule, specifying the time points for testing (e.g., 0, 1, 2, 4, and 6 months of light exposure).
Prepare Study Protocol
1. Prepare and approve the study protocol, including test parameters, exposure conditions, and sampling methods.
2. Ensure the protocol is aligned with ICH Q1B guidelines for photostability testing and other relevant regulatory standards.
Label and Identify Samples
1. Label all sample containers clearly with product details, batch number, light exposure conditions, and the start date of the study.
Prepare Exposure Chamber
1. Ensure that the photostability chamber is properly calibrated and that light intensity and exposure duration are set as per the study protocol.

5.2 Conducting the Photostability Study

Follow these steps during the study:

Expose Capsules to Light
1. Place the samples in the photostability chamber under the defined light intensity and exposure conditions.
2. Monitor and record the exposure conditions throughout the study period to ensure they remain within the specified limits.
Monitor Light Exposure
1. Periodically check the exposure levels in the chamber to ensure that they align with the requirements specified in the study protocol.
2. Ensure that light exposure is consistent and uninterrupted throughout the duration of the study.
Periodic Sampling
1. At each specified time point, remove a sample of capsules from the chamber for testing.
2. Document the date and time of sampling, as well as the light exposure conditions at that time.
Conduct Testing on Samples
1. Test the capsules for relevant parameters such as potency, dissolution, disintegration, appearance, and moisture content.
2. Record any changes or degradation observed in the capsules compared to the baseline or control samples.

5.3 Data Analysis and Reporting

After completing the study, ensure the following:

Evaluate Stability Data
1. Analyze the data to assess the impact of light exposure on the capsules, including any degradation or loss of potency.
2. Compare the results with the acceptance criteria defined in the study protocol to determine if the capsules remain within quality specifications.
Prepare Stability Report
1. Prepare a detailed photostability study report that includes the test parameters, results, data analysis, and conclusions regarding the stability of the capsules under light exposure.
2. Include any recommendations for improvements in the formulation or packaging to protect against light degradation if needed.
Review and Approval
1. Ensure that the report is reviewed by the QC and Regulatory Affairs teams for accuracy, completeness, and regulatory compliance.
2. The report must be approved by the Quality Control Manager before submission for regulatory filing or product release decisions.

5.4 Post-Study Actions

After completing the photostability study, ensure the following:

Archive Study Data
1. Ensure that all raw data, test results, and reports are archived in compliance with the company’s data retention policy and regulatory requirements.
2. Maintain the study records in a secure location for future reference and audits.
Review Study for Product Release
1. Review the photostability data to determine whether the batch of capsules meets the required standards for light stability and is suitable for release.

6. Abbreviations

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

7. Documents

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

8. References

ICH Q1B – Stability Testing: Photostability Testing of New Drug Substances and Products
Good Manufacturing Practice (GMP) Guidelines
USP <701> – Disintegration of Tablets and Capsules

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Photostability Study Protocol

Study ID	Product Name	Batch Number	Start Date	End Date	Light Exposure Conditions	Sampling Timepoints
SS-003	Capsule C	Batch 024	01/02/2025	01/02/2026	1.2 million lux hours, Fluorescent Light	0, 1, 2, 4, 6 months

Annexure 2: Stability Testing Data Record

Batch ID	Test Date	Test Parameter	Initial Value	Final Value	Deviation
Batch 024	07/02/2025	Potency	98%	97%	None

Annexure 3: Photostability Study Report

Batch ID	Final Test Date	Test Parameter	Result	Conclusions
Batch 024	01/02/2026	Potency	95%	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 photostability testing	QA Head
01/02/2025	2.0	Updated testing parameters and sampling intervals	Inclusion of additional test parameters for light degradation analysis	QA Head

Exit mobile version