corrective actions are implemented as needed.

Maintenance Team: Responsible for ensuring that the equipment used for in-process testing is properly maintained and calibrated according to the established schedule.

Engineering Team: Responsible for supporting the production and QA teams in resolving any issues related to testing equipment or deviations from the established process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all in-process test results are recorded and documented according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. In-Process Test Planning

1. Before manufacturing begins, identify the critical process parameters and in-process tests to be conducted during production. These tests should be based on the product specifications and include tests such as:
   • Weight checks
   • Fill volume tests
   • Pressure tests
   • Particle size analysis
   • Other product-specific tests
2. Ensure that all in-process tests have clear acceptance criteria defined. The acceptance criteria should be documented in the Batch Manufacturing Record (BMR) or Product Control Record (PCR).
3. Confirm that all required testing equipment is available, calibrated, and functioning properly. Calibration records for equipment should be reviewed and maintained in accordance with the relevant SOPs.

5.2. Performing In-Process Tests

1. Perform in-process tests according to the defined testing schedule and product specifications. Record the test results immediately after the test is performed.
2. In-process test results should include:
   • The specific parameter being tested (e.g., weight, fill volume)
   • The results of the test, including units and measurement scale
   • The date and time of testing
   • The name or ID of the operator performing the test
   • Any observations or remarks, including any deviations from the expected results
3. All in-process test results must be recorded in the designated In-Process Testing Log (Annexure-1), ensuring that the log is updated in real-time as the tests are performed.

5.3. Documenting In-Process Test Results

1. For each in-process test, document the results in the In-Process Testing Log (Annexure-1). The log should include the following information for each test:
   • Batch number and product name
   • Test type and description
   • Test results with units
   • Test date and time
   • Name or ID of the operator performing the test
   • Any corrective actions taken in case of deviation
2. Ensure that the In-Process Testing Log is signed and dated by the operator performing the test and that the results are verified by a supervisory or QA personnel.
3. In the event of any deviations from the expected results, document the deviation in the Deviation Log (Annexure-2) and follow the appropriate corrective and preventive action (CAPA) process.

5.4. Reviewing and Approving In-Process Test Results

1. Once the in-process test results are recorded, the QA team should review the data to ensure compliance with product specifications and GMP requirements.
2. If the test results meet the acceptance criteria, the results should be approved by the QA team and stored in the appropriate batch record.
3. If the test results do not meet the acceptance criteria, the QA team should investigate the cause of the deviation and initiate corrective actions. The investigation and corrective actions should be documented in the Deviation Log (Annexure-2).

5.5. Archiving In-Process Test Results

1. After the in-process test results have been reviewed and approved, they should be archived in accordance with company policies and regulatory requirements.
2. In-process test records should be kept for the required retention period and stored securely for easy retrieval during audits, inspections, or investigations.
3. Ensure that in-process test records are organized and easily accessible to authorized personnel when needed.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• BMR: Batch Manufacturing Record
• PCR: Product Control Record
• QC: Quality Control

7. Documents

1. In-Process Testing Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: In-Process Testing Log

Batch Number	Test Type	Test Results	Test Date	Operator	Remarks
BN-12345	Weight Check	50g	06/02/2025	Rajesh Patel	Pass
BN-12345	Fill Volume	200ml	06/02/2025	Rajesh Patel	Pass

Annexure-2: Deviation Log

Deviation ID	Description	Corrective Action	Responsible Person	Status
DEV-12345	Fill volume deviation	Adjusted filling machine settings	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Recalibrated fill volume settings	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated in-process testing procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures