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)

1. Review the product development information, including formulation, process design, and regulatory requirements, to identify potential CQAs.
2. Consider the following potential CQAs:
   • Tablet weight
   • Tablet hardness
   • Dissolution rate
   • Disintegration time
   • Content uniformity
   • Impurity levels
3. Use scientific knowledge, historical data, and risk-based assessments to determine which attributes are critical for the quality of the tablet.
4. Document all identified CQAs, including justifications for why they are critical (Annexure-1).

5.2 Defining CQAs

1. For each identified CQA, define the specifications, including the acceptable limits and test methods.
2. Specify how each CQA will be monitored throughout the manufacturing process and the associated control limits (Annexure-2).
3. 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

1. 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
2. Ensure that appropriate in-process controls and testing methods are established for each CQA.

5.4 Monitoring CQAs During Manufacturing

1. Monitor each CQA throughout the manufacturing process using real-time data collection and testing protocols.
2. Document all monitoring results and compare them against pre-established control limits (Annexure-3).
3. If any CQA falls outside of the defined limits, initiate corrective actions immediately to resolve the issue.

5.5 Reviewing and Updating CQAs

1. Regularly review the CQAs to ensure they remain relevant and aligned with the current product requirements and manufacturing practices.
2. Update the list of CQAs if new risks or quality issues are identified or if changes are made to the manufacturing process.
3. Document all updates to CQAs and review them as part of the annual product review process (Annexure-4).

5.6 Documentation and Record Keeping

1. Maintain records of all identified CQAs, including specifications, acceptance criteria, and monitoring results (Annexure-5).
2. Ensure that all documentation is stored securely and accessible for audits and inspections.
3. 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

1. Critical Quality Attributes Documentation (Annexure-1)
2. CQA Specifications and Control Limits (Annexure-2)
3. CQA Monitoring Data (Annexure-3)
4. Annual Review of CQAs (Annexure-4)
5. 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