at specified stages of production and that corrective actions are taken when deviations occur.

Engineering Team: Responsible for ensuring that the equipment used in in-process testing is calibrated and maintained in accordance with regulatory standards.

4. Accountability

The QA Manager is accountable for overseeing the validation of in-process testing and ensuring that it meets regulatory and quality standards. The QC Supervisor is responsible for the execution and documentation of in-process tests. The Production Supervisor ensures that in-process testing is carried out at the designated stages of production.

5. Procedure

5.1 Pre-Validation Setup

Before initiating the validation process for in-process testing, ensure the following steps are completed:

1. Review Validation Plan
   1. Review and approve the in-process testing validation plan, including the test parameters, methods, and acceptance criteria. Ensure that the validation plan is approved by the QA department before implementation.
2. Define In-Process Test Parameters
   1. Identify the critical quality attributes that will be tested in-process, such as capsule weight, hardness, dissolution, and content uniformity. Ensure these tests are representative of the final product quality.
3. Prepare In-Process Samples
   1. Prepare representative samples of capsules from various stages of the production process, ensuring they accurately represent the full range of variability (e.g., low, high, and normal values for weight and content uniformity).
4. Calibrate Testing Equipment
   1. Ensure that all equipment used for in-process testing, such as hardness testers, dissolution apparatus, and balances, are calibrated according to the manufacturer’s specifications. Document calibration details in the Equipment Calibration Log (Annexure 1).

5.2 In-Process Testing Validation

Perform the following steps to validate the in-process testing methods:

1. Test Execution
   1. Perform the in-process tests on the prepared samples. The tests should include parameters such as weight variation, content uniformity, hardness, dissolution, and visual inspection for defects.
2. Critical Parameter Monitoring
   1. Ensure that each in-process test is conducted at the appropriate stage of production (e.g., after capsule filling, before sealing, after drying). Monitor parameters such as capsule weight, size, and hardness to detect any deviations from specified limits.
3. Test Data Analysis
   1. Analyze the results of the in-process tests to confirm that they meet the defined acceptance criteria. If any test results are out-of-specification (OOS), immediately initiate corrective actions and investigate the cause.
4. Documentation of Results
   1. Document all in-process test results in the In-Process Test Log (Annexure 2). This should include test parameters, results, and any deviations or corrective actions taken.

5.3 Post-Validation Activities

After the in-process testing validation is complete, ensure the following actions are taken:

1. Approval of Results
   1. The QA Manager reviews the in-process testing results and ensures that they meet all specifications. Approve the validation results for use in routine production.
2. Personnel Training
   1. Train the production and QC teams on the validated in-process testing procedures, including how to perform the tests, interpret results, and handle deviations.
3. Routine Monitoring
   1. Implement routine monitoring of in-process tests during production. Ensure that all tests are carried out as per the validated procedures and that deviations are investigated and resolved.
4. Documentation and Record Keeping
   1. Archive all in-process testing documentation, including the test logs, calibration records, and deviation reports, in compliance with regulatory retention requirements.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• R&D: Research and Development
• RH: Relative Humidity
• OOS: Out of Specification

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: In-Process Test Log
3. Annexure 3: In-Process Test Results Report

8. References

• FDA Guidance on In-Process Testing and Controls
• Good Manufacturing Practice (GMP) Guidelines
• USP <1225> – Validation of Compendial Methods

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
Capsule Hardness Tester 320	01/02/2025	John Doe	Calibration of force and test speed	01/02/2026

Annexure 2: In-Process Test Log

Sample ID	Test Date	Test Type	Results	Remarks
Sample 001	02/02/2025	Weight Uniformity	Pass	Within acceptable limits

Annexure 3: In-Process Test Results Report

Batch ID	Test Date	Test Parameters	Results	Deviation
Batch 001	02/02/2025	Content Uniformity	Pass	None

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 in-process testing validation	QA Head
01/02/2025	2.0	Added new testing methods and updated parameters	Enhancement of test procedures and standardization	QA Head