Stability Testing Procedures for Capsules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting stability tests to determine the shelf life and appropriate storage conditions for capsules.

2) Scope

This SOP applies to all capsules produced within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting stability tests.
– Production personnel must provide samples of capsules for testing.
– QA personnel are responsible for reviewing and approving the test results.

4) Procedure

1. Sample Collection
1.1. Collect representative samples of capsules from each production batch.
1.2. Ensure samples are collected at regular intervals during the production process.
1.3. Label each sample with batch number, date of collection, and storage conditions.
2. Storage Conditions
2.1. Store samples under different conditions to simulate real-world scenarios, including:
2.1.1. Accelerated conditions (e.g., 40°C/75% RH)
2.1.2. Long-term conditions (e.g., 25°C/60% RH)
2.1.3. Intermediate conditions if necessary
3. Stability Testing
3.1. Conduct stability tests at predefined intervals (e.g., 0, 3, 6, 12, 24 months).
3.2. Test for key parameters, including:
3.2.1. Physical appearance (e.g., color, shape)
3.2.2. Assay of active ingredients
3.2.3. Degradation products
3.2.4. Moisture content
3.2.5. Dissolution profile
3.2.6. Microbial limits
4. Documentation
4.1. Record all test results in the stability testing log.
4.2. Include details such as batch number, date of testing, storage conditions, and results.
4.3. Sign and date the testing log.
5. Data Analysis
5.1. Analyze the data to determine trends and identify any degradation over time.
5.2. Compare results to predetermined acceptance criteria.
6. Shelf Life Determination
6.1. Use the stability data to determine the shelf life of the capsules.
6.2. Recommend appropriate storage conditions based on the data analysis.
7. Review and Approval
7.1. Submit the completed testing logs and data analysis to the QA department for review.
7.2. QA will review and approve the results based on the criteria outlined in this SOP.
8. Corrective Actions
8.1. If stability tests indicate issues with the product, initiate a corrective action report.
8.2. Document all actions taken to address issues identified during testing, including potential adjustments to the formulation or packaging.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– RH: Relative Humidity

6) Documents, if any

– Stability Testing Log
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q1A(R2) – Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0