Standard Operating Procedure for Reviewing In-Process Quality Control Results

Department	Tablet
SOP No.	SOP/TAB/202/2025
Supersedes	SOP/TAB/202/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To establish the procedure for reviewing in-process quality control (IPQC) results to ensure that tablet manufacturing processes remain within predefined specifications and regulatory requirements.

2. Scope

This SOP applies to all tablet manufacturing processes, including raw material inspection, granulation, compression, coating, and final product inspection. It covers the review of IPQC results at each stage of production to ensure ongoing product quality.

3. Responsibilities

• Quality Assurance (QA): Responsible for overseeing the review of IPQC results and ensuring that the manufacturing process meets regulatory requirements and internal standards.
• Quality Control (QC): Responsible for performing the in-process quality control testing and documenting the results accurately. QC is also responsible for notifying QA if any test result falls outside the acceptable range.
• Production Team: Responsible for promptly addressing any deviations identified during the IPQC process and notifying QC and QA teams for further evaluation.

4. Accountability

The QA Manager is accountable for ensuring that all in-process quality control results are reviewed timely and accurately. The QC Manager is responsible for conducting the tests and maintaining records of all IPQC results.

5. Procedure

5.1 Collection of IPQC Samples

1. Collect samples from the production line at predefined intervals based on the production schedule and product specifications.
2. Ensure that samples are collected using approved equipment and methods to avoid contamination or error.
3. Label the samples with the necessary details such as batch number, production date, and time of sampling.

5.2 Conducting IPQC Testing

1. Perform in-process quality control testing on the collected samples according to the relevant test procedures outlined in the SOPs.
2. Test parameters may include weight variation, hardness, friability, thickness, uniformity, dissolution, and other required properties.
3. Record the results of the IPQC tests in the IPQC log (Annexure-1) along with any relevant observations during testing.
4. If results fall outside the acceptable range, immediately inform the QA and production teams for further investigation and corrective actions.

5.3 Reviewing IPQC Results

1. QA reviews the recorded IPQC results to ensure that all results fall within the established specifications. Results should be compared with the target values and any established acceptance criteria.
2. If any test result deviates from the acceptable range, QA must investigate the cause of the deviation and determine the impact on the quality of the product.
3. If the deviation is minor and can be corrected immediately, it should be addressed by the production team with the assistance of QC. If it is significant, further investigations, including a review of batch records, equipment calibration, and raw material quality, should be initiated.
4. QA should document all review findings in the review log (Annexure-2) and ensure that corrective actions, if needed, are clearly outlined.

5.4 Corrective and Preventive Actions (CAPA)

1. If a deviation is identified during the review, initiate a Corrective and Preventive Action (CAPA) process to address the root cause of the issue.
2. QA and QC work with the production team to investigate and identify the root cause of the deviation. Use tools such as root cause analysis or fishbone diagrams if necessary (Annexure-3).
3. Develop corrective actions to address the immediate issue, and implement preventive actions to prevent recurrence in future batches.
4. Ensure that CAPA records are maintained and documented properly for follow-up and auditing purposes (Annexure-4).

5.5 Verification of Corrective Actions

1. Verify the effectiveness of corrective and preventive actions taken. This may include re-testing, reviewing the process changes, and monitoring the impact on subsequent batches.
2. If the corrective actions were successful in addressing the deviation, close the CAPA and document the findings in the CAPA follow-up log (Annexure-5).
3. If the corrective actions were not effective, re-initiate the CAPA process and review additional solutions or adjustments that may be necessary.

5.6 Final Review and Approval

1. QA conducts the final review of the batch to confirm that all IPQC results are acceptable and that all deviations have been addressed.
2. Once all IPQC results and corrective actions are reviewed and validated, approve the batch for the next production step or release for final testing (Annexure-6).

5.7 Documentation and Record Keeping

1. Maintain all IPQC results, deviation reports, CAPA documentation, and batch review logs for regulatory compliance and future reference.
2. Ensure that all records are easily accessible and stored in a secure, organized manner, and that they are retained for the required period as per regulatory guidelines.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• IPQC: In-Process Quality Control

7. Documents

1. IPQC Log (Annexure-1)
2. Review Log (Annexure-2)
3. Root Cause Analysis (Annexure-3)
4. CAPA Documentation (Annexure-4)
5. CAPA Follow-up Log (Annexure-5)
6. Batch Review Log (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide 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: IPQC Log

Sample ID	Test Conducted	Result	Operator	Date
Sample-123	Weight Variation	Pass	John Doe	01/03/2026

Annexure-2: Review Log

Sample ID	Test Results	Reviewer	Comments	Approval Status
Sample-123	Pass	Jane Smith	Reviewed; all results within range	Approved

Annexure-3: Root Cause Analysis

RCA ID	Deviation Description	Root Cause	Corrective Action
RCA-001	Tablet Weight Deviation	Incorrect tablet press setting	Re-calibrated tablet press

Annexure-4: CAPA Documentation

CAPA ID	Action Description	Completion Date	Responsible Person
CAPA-001	Adjusted press settings to ensure weight uniformity	01/04/2026	John Doe

Annexure-5: CAPA Follow-up Log

CAPA ID	Follow-up Action	Completion Date	Status
CAPA-001	Rechecked tablet press settings	01/05/2026	Completed

Annexure-6: Batch Review Log

Batch Number	IPQC Status	Review Date	Final Approval
Batch-12345	Pass	01/03/2026	Approved

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated IPQC review process	Improved monitoring and documentation	QA Head