Pharmaceutical QC Laboratory Inspection Checklist
QC laboratory GMP compliance is critical to ensuring test results supporting batch release are accurate and reliable. This quarterly inspection checklist covers all key elements of 21 CFR Part 211 Subpart I laboratory controls requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Quarterly
- Estimated Time: 45-60 minutes
- Role: QA Manager / Laboratory Manager
- Total Items: 31
- Compliance: FDA 21 CFR Part 211 Subpart I - Laboratory Controls, FDA 21 CFR 211.160 - General Requirements for Laboratory Controls, FDA 21 CFR 211.194 - Laboratory Records, USP General Chapter <1058> Analytical Instrument Qualification
Analyst Qualification and Training
Verify analyst training and method qualification.
- All analysts with current training records for methods they perform?
- Analyst qualification samples tested with passing results on file?
- Training matrix current showing method qualification status for each analyst?
- Laboratory safety training (chemical, biological, radiation) current?
- Qualified laboratory supervisor present during operations?
Instruments and Calibration
Verify instrument qualification and calibration.
- All analytical instruments with current calibration certificates?
- IQ/OQ/PQ qualification completed for all critical instruments per USP <1058>?
- Equipment logbooks current with use, cleaning, and maintenance records?
- System suitability tests performed and passing for chromatographic methods?
- Analytical balances calibrated and daily performance check completed?
Reagents, Solvents, and Reference Standards
Verify reagent and reference standard management.
- All reagents labeled with receipt date, opened date, expiration, and responsible person?
- No expired reagents in use?
- Reference standards from compendial or qualified secondary source with documented potency?
- Reference standards stored under controlled conditions with restricted access?
- Reference standard use log maintained?
Sample Management
Verify sample handling and chain of custody.
- All samples properly labeled with batch, sampler, date, and storage conditions?
- Samples segregated by status (quarantine, approved, rejected) and product?
- Retain samples stored per 21 CFR 211.170 requirements?
- Sample disposal procedures followed and documented?
- Chain of custody maintained for all samples?
Test Methods and OOS Procedures
Verify test method and OOS management.
- Current, approved method versions in use in laboratory?
- OOS procedure implemented per FDA OOS Guidance (2006)?
- Phase I (laboratory investigation) and Phase II (full investigation) documented for OOS events?
- Invalidated results only with documented assignable cause?
- No pattern of selective result reporting or testing into compliance?
Laboratory Records and Documentation
Verify laboratory record completeness and integrity.
- Laboratory notebooks or worksheets completed per GDP?
- Chromatographic data files preserved with original raw data?
- Audit trails reviewed for all GxP computerized laboratory systems?
- Laboratory records retained per 21 CFR 211.194 (minimum 1 year after expiry)?
- Calculations independently verified or system-verified?
- Complete laboratory inspection report prepared?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Microbiological Contamination Testing Checklist
- Pharmaceutical Water System Inspection Checklist
- Pharmaceutical Microbiological Contamination Testing Checklist
- Pharmaceutical Supplier Qualification Audit Checklist
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist
- Pharmaceutical Packaging Materials Audit and Inspection Checklist
- GxP Training Compliance and Competency Audit Checklist
Related Laboratory Checklists
- Pharmaceutical Microbiological Contamination Testing Checklist - FREE Download
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Why Use This Pharmaceutical QC Laboratory Inspection Checklist?
This pharmaceutical qc laboratory inspection checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / laboratory manager professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: quarterly.
Ensures compliance with FDA 21 CFR Part 211 Subpart I - Laboratory Controls, FDA 21 CFR 211.160 - General Requirements for Laboratory Controls, FDA 21 CFR 211.194 - Laboratory Records, USP General Chapter <1058> Analytical Instrument Qualification. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical QC Laboratory Inspection Checklist cover?
This checklist covers 31 inspection items across 6 sections: Analyst Qualification and Training, Instruments and Calibration, Reagents, Solvents, and Reference Standards, Sample Management, Test Methods and OOS Procedures, Laboratory Records and Documentation. 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 QC Laboratory Inspection Checklist?
This checklist is designed for QA Manager / Laboratory 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.