according to GMP guidelines. The QC Supervisor ensures that testing is performed properly, and the Production Supervisor ensures that capsule batches meet the required quality standards.

5. Procedure

5.1 Pre-Testing Setup

Before performing the acid resistance testing, ensure the following:

1. Review Material Specifications
   1. Review the specifications for the enteric-coated capsules to confirm that they are designed to resist acid exposure, particularly at the pH level typical for gastric conditions (pH 1.2).
2. Prepare Testing Equipment
   1. Ensure that the disintegration testing apparatus is calibrated and set up according to the prescribed standards (e.g., USP <701> for disintegration).
   2. Prepare the test medium, which should consist of a simulated gastric fluid (SGF) at pH 1.2.
3. Sample Collection
   1. Collect a representative sample of the enteric-coated capsules from the batch. Typically, 6 capsules are selected for testing, but this may vary depending on batch size and regulatory guidelines.

5.2 Acid Resistance Testing Procedure

Follow these steps to conduct the acid resistance test:

1. Set Up the Disintegration Apparatus
   1. Place the disintegration testing apparatus in the proper location and ensure the bath is filled with the pre-warmed SGF at pH 1.2 (simulated gastric fluid).
   2. Ensure the apparatus is operating at the correct temperature (37°C ± 2°C) to simulate physiological conditions.
2. Test the Capsules
   1. Place each capsule in the disintegration basket of the apparatus. Start the testing cycle and observe the capsules for any signs of disintegration.
   2. Continue the test for up to 2 hours or until the capsule’s coating begins to dissolve or the capsule disintegrates.
3. Observation and Documentation
   1. Note the time at which the enteric coating begins to dissolve or when disintegration occurs. The capsules should not show any sign of disintegration during the first 60 minutes in the acidic medium.
   2. Record the time taken for each capsule to show any disintegration or coating damage.

5.3 Post-Testing Activities

After completing the acid resistance test, ensure the following:

1. Review Results
   1. The QA Manager reviews the test results to ensure that the enteric-coated capsules meet the acceptance criteria, i.e., the capsules should not disintegrate in SGF at pH 1.2 within the first 60 minutes of testing.
2. Corrective Actions
   1. If any capsules fail the acid resistance test (e.g., coating dissolves prematurely), the batch should be rejected, and an investigation should be initiated to identify the root cause.
3. Reporting
   1. Provide the test results to the regulatory authorities if required, especially if any deviations or failures are encountered during testing.
4. Record Keeping
   1. Ensure that all test results, observations, and corrective actions are properly documented and archived in accordance with GMP and regulatory guidelines.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• SGF: Simulated Gastric Fluid
• USP: United States Pharmacopeia
• EP: European Pharmacopeia

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Acid Resistance Testing Log
3. Annexure 3: Corrective Action Report

8. References

• USP <701> – Disintegration of Tablets and Capsules
• European Pharmacopoeia 2.9.1 – Dissolution Testing
• 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: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Disintegration Apparatus 301	01/02/2025	John Doe	Calibration of temperature and timing mechanism	01/02/2026

Annexure 2: Acid Resistance Testing Log

Batch ID	Test Date	Disintegration Time (Minutes)	Result	Comments
Batch 010	02/02/2025	60	Pass	No coating damage

Annexure 3: Corrective Action Report

Batch ID	Deviation	Corrective Action	Responsible Person	Completion Date
Batch 010	Coating dissolution at 45 minutes	Adjusted coating process parameters	Production Supervisor	03/02/2025

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 testing enteric coating	QA Head
01/02/2025	2.0	Updated test method and log format	Improvement of testing accuracy and compliance	QA Head