Pharmaceutical Equipment Calibration and Validation Inspection Checklist

Equipment qualification and calibration are foundational GMP requirements ensuring product quality and process consistency. This inspection checklist verifies calibration compliance, validation status, and data integrity for all pharmaceutical manufacturing equipment.

Industry: Pharmaceutical & Life Sciences
Frequency: Quarterly
Estimated Time: 45-60 minutes
Role: Validation Engineer / QA Manager
Total Items: 33
Compliance: FDA 21 CFR 211.68 Automatic Mechanical and Electronic Equipment, EU GMP Annex 15 Qualification and Validation, EU GMP Annex 11 Computerised Systems, FDA 21 CFR Part 11 Electronic Records Electronic Signatures, GAMP 5 Risk-Based Approach to GxP Computerized System Validation

Calibration Program

Review calibration schedule and compliance.

Master calibration schedule established for all critical instruments?
No instruments in use with overdue calibration?
All instruments have current calibration stickers with due date?
No instruments found out of tolerance during calibration not investigated?
Calibration records stored and available for review?
External calibration laboratory accredited to ISO/IEC 17025?

Equipment Qualification Status

Verify equipment qualification (IQ/OQ/PQ) compliance.

All critical equipment has approved IQ/OQ/PQ qualification on file?
Periodic requalification completed per qualification master plan schedule?
Equipment changes triggering requalification identified and executed?
Qualification reports approved by QA before equipment released for use?
Validation Master Plan (VMP) current and approved?

Computerized Systems and Data Integrity

Verify computerized system validation and data integrity controls.

All GxP computerized systems validated per GAMP 5 risk-based approach?
Electronic audit trails enabled for all GMP data systems?
User access controls implemented (role-based, individual accounts, no shared logins)?
Regular data backup and restoration tested?
Electronic signatures compliant with 21 CFR Part 11 (if applicable)?
No shadow spreadsheets or unofficial data repositories in use?

Preventive Maintenance

Review preventive maintenance program.

Preventive maintenance schedule established for all critical equipment?
No critical equipment with overdue preventive maintenance?
PM records on file documenting work performed?
Equipment use and maintenance logbooks maintained?
Critical spare parts inventory maintained to minimize downtime?

Critical Utilities and Process Equipment

Verify critical utility qualification.

HVAC system qualification current per EU GMP Annex 1 and ISPE HVAC Guide?
Purified water and WFI system qualification current?
Clean steam system qualification current?
All product-contact process equipment qualified (granulators, blenders, fillers)?
CIP/SIP systems validated for cleaning and sterilization?

Documentation and Change Control

Verify calibration documentation and change management.

Master instrument list current with all additions and retirements?
Retired instruments removed from calibration schedule and labeled?
Changes to calibration procedures going through change control?
Out-of-tolerance calibrations documented with impact assessment?
All personnel performing calibrations trained and qualified?
Validation program reviewed annually and revalidation needs assessed?

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Why Use This Pharmaceutical Equipment Calibration and Validation Inspection Checklist?

This pharmaceutical equipment calibration and validation inspection checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for validation engineer / qa manager professionals, this checklist covers 33 critical inspection points across 6 sections. Recommended frequency: quarterly.

Ensures compliance with FDA 21 CFR 211.68 Automatic Mechanical and Electronic Equipment, EU GMP Annex 15 Qualification and Validation, EU GMP Annex 11 Computerised Systems, FDA 21 CFR Part 11 Electronic Records Electronic Signatures, GAMP 5 Risk-Based Approach to GxP Computerized System Validation. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Pharmaceutical Equipment Calibration and Validation Inspection Checklist cover?

This checklist covers 33 inspection items across 6 sections: Calibration Program, Equipment Qualification Status, Computerized Systems and Data Integrity, Preventive Maintenance, Critical Utilities and Process Equipment, Documentation and Change Control. It is designed for pharmaceutical & life sciences operations and compliance.

How often should this checklist be completed?

This checklist should be completed quarterly. Each completion takes approximately 45-60 minutes.

Who should use this Pharmaceutical Equipment Calibration and Validation Inspection Checklist?

This checklist is designed for Validation Engineer / QA Manager professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.