SOP Guide for Pharma

Tablets: SOP for QA Oversight During Equipment Qualification – V 2.0

Auditor

Tablets: SOP for QA Oversight During Equipment Qualification – V 2.0

Standard Operating Procedure for QA Oversight During Equipment Qualification

Department Tablet
SOP No. SOP/TAB/224/2025
Supersedes SOP/TAB/224/2022
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 establish the procedures for ensuring that Quality Assurance (QA) is involved in equipment qualification throughout the tablet manufacturing process. This ensures that equipment operates within the required specifications and meets both regulatory and internal quality standards.

2. Scope

This SOP applies to all equipment used in tablet manufacturing processes, including mixing, granulation, compression, coating, and packaging equipment. It covers all stages of equipment qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

3. Responsibilities

  • QA Manager: Responsible for overseeing the equipment qualification process, ensuring proper documentation, and ensuring compliance with regulatory standards.
  • Production Team: Responsible for performing qualification activities and ensuring that equipment operates according to the specified requirements.
  • Engineering Team: Responsible for assisting in the installation, calibration, and troubleshooting of equipment and ensuring that all equipment is in good working condition during the qualification process.
  • Regulatory Affairs Team: Ensures that the equipment qualification process meets all applicable regulatory requirements.

4. Accountability

The QA Manager is accountable for ensuring the QA oversight during equipment qualification. The Engineering and Production teams are responsible for carrying out the qualification activities, while the QA team ensures compliance and provides guidance throughout the process.

See also  Tablets: SOP for Compression Force Impact Analysis on Tablet Hardness - V 2.0

5. Procedure

5.1 Pre-Qualification Preparation

  1. Review the equipment specifications, installation manual, and user requirements document (Annexure-1) to understand the operational limits and expected performance.
  2. Ensure that the necessary calibration tools, test equipment, and qualified personnel are available before initiating the qualification process.
  3. Review the equipment supplier’s qualification documentation and previous service records to ensure compliance with industry standards.

5.2 Installation Qualification (IQ)

  1. Verify that the equipment has been installed according to the manufacturer’s specifications and that it is in the correct location (Annexure-2).
  2. Ensure that all equipment is properly connected to utilities (e.g., power, water, compressed air) and that safety features are fully operational.
  3. Document the completion of the installation, including photographs and installation checklists (Annexure-3).
  4. Ensure that all equipment documentation is available, including operator manuals, safety protocols, and maintenance schedules.

5.3 Operational Qualification (OQ)

  1. Verify that the equipment operates according to the specified operational limits and performs as expected under normal operating conditions (Annexure-4).
  2. Test all control features, alarms, and safety systems to ensure they function properly.
  3. Document all OQ testing results, including any deviations or failures, and report them to the QA department (Annexure-5).
  4. Ensure that the equipment is capable of operating consistently within the required parameters for tablet manufacturing.

5.4 Performance Qualification (PQ)

  1. Conduct performance qualification tests to verify that the equipment consistently produces product within the required quality specifications under actual operating conditions (Annexure-6).
  2. Monitor the equipment performance for stability and reliability over a defined batch size or period.
  3. Document the performance results, including any adjustments or corrective actions taken, and ensure they are reviewed and approved by QA (Annexure-7).
See also  Tablets: SOP for Documentation of Stability Study Results - V 2.0

5.5 Documentation and Record Keeping

  1. Ensure that all qualification documents, including IQ, OQ, and PQ records, are completed, signed, and filed according to the company’s document control procedures (Annexure-8).
  2. Store all qualification records for a minimum of 5 years or as required by regulatory guidelines.
  3. Ensure that all equipment qualification records are accessible for audits and inspections.

5.6 Ongoing Monitoring and Re-Qualification

  1. Monitor equipment performance during routine use to ensure continued compliance with operational limits (Annexure-9).
  2. Re-qualify the equipment after any significant repairs, upgrades, or changes in operating conditions that could impact equipment performance.
  3. Document any re-qualification activities and maintain the records in the appropriate equipment qualification file.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • IQ: Installation Qualification

7. Documents

  1. Equipment Qualification Report (Annexure-1)
  2. Installation Qualification Checklist (Annexure-2)
  3. Installation Verification Report (Annexure-3)
  4. Operational Qualification Test Plan (Annexure-4)
  5. Operational Qualification Test Results (Annexure-5)
  6. Performance Qualification Test Plan (Annexure-6)
  7. Performance Qualification Test Results (Annexure-7)
  8. Qualification Documentation Log (Annexure-8)
  9. Ongoing Equipment Monitoring Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • ISO 9001 – Quality Management Systems
  • GMP Guidelines for Pharmaceutical Manufacturing
See also  Tablets: SOP for Scaling Up Sugar Coating for Commercial Production - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Qualification Report

Equipment Model Serial Number Manufacturer Qualification Date
Tablet Press Model A 123456 Manufacturer ABC 01/03/2026

Annexure-2: Installation Qualification Checklist

Item Specification Pass/Fail Comments
Power Supply 220V, 50Hz Pass Connected and tested

Annexure-3: Installation Verification Report

Equipment Location Installed By Verification Date
Tablet Press Production Area 1 John Smith 01/03/2026

Annexure-4: Operational Qualification Test Plan

Test Specification Acceptance Criteria
Tablet Hardness 30 N Pass

Annexure-5: Operational Qualification Test Results

Test Result Pass/Fail
Tablet Hardness 31 N Pass

Annexure-6: Performance Qualification Test Plan

Test Specification Acceptance Criteria
Tablet Weight 500 mg ±5% of specification

Annexure-7: Performance Qualification Test Results

Test Result Pass/Fail
Tablet Weight 510 mg Pass

Annexure-8: Qualification Documentation Log

Document Type Storage Location Retention Period
Qualification Report QA Archive 5 years

Annexure-9: Ongoing Equipment Monitoring Log

Monitoring Parameter Frequency Action Taken
Tablet Hardness Daily Adjusted pressure

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 Added requalification and ongoing monitoring procedures Process improvement QA Head
Exit mobile version