Standard Operating Procedure for Establishing Critical Quality Attributes (CQAs) for Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/220/2025 |
| Supersedes | SOP/TAB/220/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
The purpose of this SOP is to define the process for establishing Critical Quality Attributes (CQAs) for tablet products. The goal is to ensure that CQAs are identified early in the product development process and are monitored throughout manufacturing to guarantee product quality and compliance with regulatory standards.
2. Scope
This SOP applies to all tablet products in the manufacturing process. It includes the identification, definition, and documentation of CQAs for each tablet product.
3. Responsibilities
- R&D Team: Responsible for identifying potential CQAs during the product development phase based on scientific knowledge and regulatory requirements.
- Quality Assurance (QA) Manager: Responsible for reviewing and approving the identified CQAs and ensuring their inclusion in manufacturing processes and control systems.
- Quality Control (QC) Team: Responsible for implementing testing protocols and monitoring CQAs during tablet manufacturing.
- Regulatory Affairs Team: Ensures that the CQAs are aligned with regulatory requirements and that all documentation is in compliance.
4. Accountability
The QA Manager is accountable for overseeing the identification and implementation of CQAs. The R&D, QC, and Regulatory Affairs teams are responsible for contributing to the process, ensuring that CQAs are appropriately defined and monitored.
5. Procedure
5.1 Identification of Critical Quality Attributes (CQAs)
- Review the product development information, including formulation, process design, and regulatory requirements, to identify potential CQAs.
- Consider the following potential CQAs:
- Tablet weight
- Tablet hardness
- Dissolution rate
- Disintegration time
- Content uniformity
- Impurity levels
- Use scientific knowledge, historical data, and risk-based assessments to determine which attributes are critical for the quality of the tablet.
- Document all identified CQAs, including justifications for why they are critical (Annexure-1).
5.2 Defining CQAs
- For each identified CQA, define the specifications, including the acceptable limits and test methods.
- Specify how each CQA will be monitored throughout the manufacturing process and the associated control limits (Annexure-2).
- Establish acceptance criteria for each CQA to ensure compliance with regulatory standards and product quality.
5.3 Incorporation of CQAs into Manufacturing and Control Systems
- Integrate the identified CQAs into the manufacturing process and control systems. This includes:
- Setting up real-time monitoring systems
- Developing standard operating procedures (SOPs) for each CQA
- Training production and QC staff on CQA monitoring and control
- Ensure that appropriate in-process controls and testing methods are established for each CQA.
5.4 Monitoring CQAs During Manufacturing
- Monitor each CQA throughout the manufacturing process using real-time data collection and testing protocols.
- Document all monitoring results and compare them against pre-established control limits (Annexure-3).
- If any CQA falls outside of the defined limits, initiate corrective actions immediately to resolve the issue.
5.5 Reviewing and Updating CQAs
- Regularly review the CQAs to ensure they remain relevant and aligned with the current product requirements and manufacturing practices.
- Update the list of CQAs if new risks or quality issues are identified or if changes are made to the manufacturing process.
- Document all updates to CQAs and review them as part of the annual product review process (Annexure-4).
5.6 Documentation and Record Keeping
- Maintain records of all identified CQAs, including specifications, acceptance criteria, and monitoring results (Annexure-5).
- Ensure that all documentation is stored securely and accessible for audits and inspections.
- Retain records for a minimum of 5 years or as required by regulatory guidelines.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- CQA: Critical Quality Attribute
7. Documents
- Critical Quality Attributes Documentation (Annexure-1)
- CQA Specifications and Control Limits (Annexure-2)
- CQA Monitoring Data (Annexure-3)
- Annual Review of CQAs (Annexure-4)
- CQA Documentation and Records (Annexure-5)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- ICH Q10 – Pharmaceutical Quality System
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: CQA Identification and Justification
| CQA | Justification |
|---|---|
| Tablet Hardness | Direct impact on tablet disintegration and dissolution performance |
Annexure-2: CQA Specifications and Control Limits
| CQA | Specification | Control Limit |
|---|---|---|
| Tablet Dissolution | 95% release within 30 minutes | ±5% of specification |
Annexure-3: CQA Monitoring Data
| Batch Number | CQA Monitored | Monitoring Result | Pass/Fail |
|---|---|---|---|
| Batch123 | Tablet Hardness | 7.5 kg | Pass |
Annexure-4: Annual Review of CQAs
| Review Date | CQA Reviewed | Changes Made |
|---|---|---|
| 01/03/2026 | Tablet Weight | Updated specification limits |
Annexure-5: CQA Documentation and Records
| Batch Number | CQA Monitored | Record Type | Retention Period |
|---|---|---|---|
| Batch123 | Tablet Hardness | Monitoring Data | 5 years |
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 monitoring and control limit procedures | Annual review | QA Head |