ensuring compliance with internal and regulatory requirements.

4. Accountability

The QC Manager is accountable for ensuring that dissolution testing is conducted in accordance with this SOP. The Production Supervisor is responsible for preparing the cream samples for dissolution testing. The QA Manager ensures that the test results are reviewed and approved in compliance with GMP and regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the necessary dissolution testing equipment is available, including dissolution apparatus (e.g., USP apparatus 2), temperature-controlled water bath, and calibrated pH meters.
2. Review the batch record to confirm the formulation details and identify the active ingredients that need to be tested for dissolution.
3. Prepare the cream samples according to the formulation and ensure they are properly homogenized and free from contamination.
4. Label each sample with the batch number, sample ID, and test date for traceability during testing.

5.2 Dissolution Testing Procedure

1. Set the dissolution apparatus to the required settings, including the specified temperature (typically 37°C ± 0.5°C) and appropriate rotation speed (typically 50-75 rpm).
2. Place the cream sample into the dissolution vessel. If the cream is semi-solid, a small quantity should be carefully introduced to avoid disturbance during the test.
3. Start the dissolution test by adding the required dissolution medium (e.g., phosphate buffer or water) to the vessel. Ensure that the medium is maintained at the correct volume and temperature throughout the test.
4. At specified time intervals (e.g., 5, 10, 15, 30, 60 minutes), take aliquots from the dissolution medium for analysis of the active ingredient content.
5. Ensure that the sample aliquots are properly filtered and analyzed using an appropriate analytical technique, such as HPLC or UV spectroscopy, to measure the active ingredient concentration in the dissolution medium.

5.3 Data Analysis and Interpretation

1. Calculate the percentage of active ingredient released at each time point. Compare the results with the established specifications for the cream formulation, which may include a required release profile over time.
2. If the release rate meets the specified criteria, mark the test as “Pass” in the Dissolution Testing Log (Annexure-1) and proceed with the next stage of production or release.
3. If the release rate does not meet the specified criteria, mark the test as “Fail.” Investigate the potential causes of failure, such as improper sample preparation, equipment malfunction, or formulation issues.

5.4 Post-Test Activities

1. Record all results, including batch number, sample ID, test date, active ingredient concentrations, and any deviations from the specifications, in the Dissolution Testing Log (Annexure-1).
2. If the dissolution test fails, initiate corrective actions, such as re-formulating the product, adjusting the dissolution medium, or modifying the manufacturing process.
3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

5.5 Documentation and Record-Keeping

1. Ensure that all dissolution testing records are complete, accurate, and securely stored. This includes the Dissolution Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• HPLC: High-Performance Liquid Chromatography
• USP: United States Pharmacopeia

7. Documents

1. Annexure-1: Dissolution Testing Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• United States Pharmacopeia (USP) Chapter <711> – Dissolution
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Dissolution Testing Log

Batch Number	Sample ID	Test Date	Time (min)	Release (%)	Operator
12345	S-001	21/01/2026	10	25%	John Doe
12345	S-001	21/01/2026	30	60%	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Release rate below specification	Reformulated batch and adjusted testing parameters	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head