Standard Operating Procedure for QA Approval of In-Process Controls
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/230/2025 |
| Supersedes | SOP/TAB/230/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/04/2026 |
| Effective Date | 06/04/2026 |
| Review Date | 01/04/2027 |
1. Purpose
The purpose of this SOP is to ensure that all in-process controls used in the manufacturing of tablets are approved by the Quality Assurance (QA) team. It ensures that all processes meet the required standards for consistency, quality, and regulatory compliance.
2. Scope
This SOP applies to all in-process controls implemented during the manufacturing process of tablets. It covers the procedures for establishing, reviewing, and approving in-process controls, including sampling, testing, and documentation.
3. Responsibilities
- QA Manager: Oversees the approval process for all in-process controls to ensure compliance with GMP and regulatory standards.
- Production Manager: Ensures that the in-process controls are applied during manufacturing and that appropriate documentation is provided for QA review.
- Quality Control (QC) Team: Performs the testing and ensures that in-process tests meet the established specifications.
- Regulatory Affairs Team: Ensures that the in-process controls comply with regulatory guidelines and standards.
4. Accountability
The QA Manager is accountable for ensuring that all in-process controls are reviewed and approved according to regulatory requirements. The Production Manager is responsible for implementing in-process controls and ensuring the accurate documentation of results.
5. Procedure
5.1 Establishment of In-Process Controls
- Identify the critical process parameters and quality attributes that require in-process controls, based on product specifications (Annexure-1).
- Develop in-process control protocols to monitor and control these parameters throughout the manufacturing process (Annexure-2).
- Ensure that the in-process controls are validated to meet the established specifications for the product (Annexure-3).
5.2 QA Review and Approval of In-Process Control Protocols
- The QA Manager reviews the in-process control protocols to ensure they align with the product’s specifications, regulatory requirements, and GMP standards (Annexure-4).
- The in-process control protocols must be signed and approved by the QA Manager before implementation in the manufacturing process (Annexure-5).
- Ensure that any changes to the in-process controls are reviewed and approved by QA before implementation (Annexure-6).
5.3 Monitoring of In-Process Controls
- During the manufacturing process, production personnel are responsible for applying the in-process controls as outlined in the approved protocol (Annexure-7).
- Ensure that production personnel document the results of in-process tests, including any deviations or non-compliance (Annexure-8).
- QC personnel should verify that the in-process control testing is conducted in accordance with the approved protocols (Annexure-9).
5.4 Review of In-Process Control Results
- QA will review the results of all in-process control tests to ensure compliance with the established specifications (Annexure-10).
- Any out-of-specification results must be documented, investigated, and corrective actions must be implemented (Annexure-11).
- QA will approve the results if they meet the specifications or take corrective action if deviations are found (Annexure-12).
5.5 Documentation and Record-Keeping
- Ensure that all in-process control records, including test results, deviations, and corrective actions, are documented and stored for review (Annexure-13).
- Ensure that all in-process control records are retained in accordance with company policy and regulatory requirements (Annexure-14).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- GMP: Good Manufacturing Practice
- CAPA: Corrective and Preventive Action
7. Documents
- In-Process Control Protocols (Annexure-1)
- In-Process Control Validation Reports (Annexure-2)
- Approved In-Process Control Protocols (Annexure-3)
- QA Review of In-Process Control Protocols (Annexure-4)
- In-Process Control Approval Form (Annexure-5)
- In-Process Control Change Control Form (Annexure-6)
- In-Process Test Results Documentation (Annexure-7)
- In-Process Test Results Review Form (Annexure-8)
- QA Review of In-Process Control Results (Annexure-9)
- Deviation Report and Investigation (Annexure-10)
- In-Process Control Approval Log (Annexure-11)
- Corrective Action Report (Annexure-12)
- In-Process Control Records Retention Log (Annexure-13)
- In-Process Control Records Storage Log (Annexure-14)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- USP <1079> – Good Storage and Distribution Practices
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 Control Protocols
| Parameter | Test Method | Acceptance Criteria | Frequency |
|---|---|---|---|
| Tablet Weight | Weight Test | ±5% of target | Every batch |
Annexure-2: In-Process Control Validation Reports
| Parameter | Method Validation | Result |
|---|---|---|
| Tablet Hardness | USP Test | Validated |
Annexure-3: Approved In-Process Control Protocols
| Protocol | Approval Date | Approved By |
|---|---|---|
| Tablet Weight Control | 01/04/2026 | QA Manager |
Annexure-4: QA Review of In-Process Control Protocols
| Protocol Name | Reviewed By | Review Date | Approval Status |
|---|---|---|---|
| Tablet Weight Protocol | John Doe | 02/04/2026 | Approved |
Annexure-5: In-Process Control Approval Form
| Parameter | Approval Date | Approved By |
|---|---|---|
| Tablet Hardness | 02/04/2026 | QA Manager |
Annexure-6: In-Process Control Change Control Form
| Change Description | Reason for Change | Approval Date |
|---|---|---|
| Frequency Change for Weight Control | Process Improvement | 03/04/2026 |
Annexure-7: In-Process Test Results Documentation
| Test Name | Test Result | Sample Size | Acceptance Criteria |
|---|---|---|---|
| Tablet Weight | 4.8 grams | 10 tablets | ±5% of target |
Annexure-8: In-Process Test Results Review Form
| Reviewed By | Review Date | Approval Status |
|---|---|---|
| Jane Smith | 04/04/2026 | Approved |
Annexure-9: QA Review of In-Process Control Results
| Review Date | Reviewed By | Comments |
|---|---|---|
| 04/04/2026 | John Doe | No issues found |
Annexure-10: Deviation Report and Investigation
| Deviation | Investigation | Corrective Action |
|---|---|---|
| Out-of-spec weight | Investigating equipment calibration | Calibrate equipment and retrain staff |
Annexure-11: In-Process Control Approval Log
| Parameter | Approval Date | Approved By |
|---|---|---|
| Tablet Hardness | 05/04/2026 | QA Manager |
Annexure-12: Corrective Action Report
| Action Taken | Completion Date | Responsible Person |
|---|---|---|
| Recalibration of hardness testing equipment | 06/04/2026 | Maintenance Manager |
Annexure-13: In-Process Control Records Retention Log
| Record Name | Retention Period | Location |
|---|---|---|
| Tablet Hardness Records | 5 years | QA Archive |
Annexure-14: In-Process Control Records Storage Log
| Record Type | Storage Location | Last Accessed |
|---|---|---|
| Tablet Weight Control Records | Digital Archive | 01/04/2026 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New process | QA Head |
| 01/02/2025 | 2.0 | Updated in-process control protocols and review process | Process improvement | QA Head |