capability needs to be established or verified for regulatory, development, or continuous improvement purposes.

3. Responsibilities

• Process Engineer: Conducts the capability study and prepares statistical data analysis.
• Production Team: Executes batches under normal manufacturing conditions and records operational data.
• Quality Control: Performs analytical testing of in-process and final samples.
• Quality Assurance: Reviews and approves final process capability reports.

4. Accountability

Manager – Manufacturing

5. Procedure

5.1 Study Preparation

1. Select the product and process step to be studied.
2. Identify critical process parameters (CPPs) and critical quality attributes (CQAs).
3. Develop a capability study protocol including data collection methodology, frequency, sample size, and statistical analysis techniques.

5.2 Data Collection

1. Execute a minimum of 20-30 production runs or units to generate adequate data points.
2. Ensure consistent operation during data collection without intentional variation.
3. Record all values for the selected parameter (e.g., viscosity, pH, fill volume, etc.).

5.3 Statistical Analysis

1. Calculate the process capability index (Cp) and process performance index (Cpk).
2. Use statistical software or validated spreadsheets for calculations.
3. Interpret results:
   • If Cp and Cpk > 1.33: Process is capable.
   • If Cp or Cpk < 1.0: Process is not capable and requires improvement.

5.4 Documentation

1. Prepare a process capability report including objective, method, data tables, graphs (histograms, control charts), Cp/Cpk values, and conclusions.
2. Attach all raw data sheets and calculations as annexures.
3. Submit the report to QA for review and approval.

5.5 Review and Actions

1. For non-capable processes, initiate root cause analysis and corrective actions.
2. Update SOPs or parameters if required based on study outcomes.

6. Abbreviations

• CPP: Critical Process Parameter
• CQA: Critical Quality Attribute
• Cp: Process Capability Index
• Cpk: Process Performance Index
• QA: Quality Assurance

7. Documents

1. Process Capability Study Protocol – Annexure-1
2. Process Capability Report – Annexure-2
3. Raw Data Sheets – Annexure-3

8. References

• ICH Q10: Pharmaceutical Quality System
• FDA Guidance on Process Validation
• ISO 22514-1: Statistical Methods in Process Capability

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Process Capability Study Protocol

Study Title	Process Capability Study of [Parameter]
Objective
Batch Numbers
Sampling Plan
Statistical Tools
Acceptance Criteria	Cp and Cpk ≥ 1.33

Annexure-2: Process Capability Report

Report Title	Process Capability Report for [Product/Parameter]
Tested Parameter
Mean
Standard Deviation
Cp
Cpk
Conclusion

Annexure-3: Raw Data Sheet

Sample No.	Test Result	Comments

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
15/04/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Added ISO standard reference and updated annexures	Regulatory alignment	QA Head