Pharmaceutical QC Laboratory Compliance Checklist [FREE PDF]
This pharmaceutical QC laboratory compliance checklist ensures quality control labs comply with FDA 21 CFR Part 211 cGMP regulations and USP general chapter requirements. Quality directors and lab managers use this to prepare for FDA Pre-Approval Inspections (PAIs) and maintain ongoing GMP compliance.
- Industry: Laboratory
- Frequency: Monthly
- Estimated Time: 30-40 minutes
- Role: QC Laboratory Manager / Quality Director
- Total Items: 9
- Compliance: FDA 21 CFR Part 211 Subpart I (laboratory controls), USP <1058> (analytical instrument qualification), FDA Guidance on Data Integrity and cGMP (2018), ICH Q2(R1) (analytical method validation)
Data Integrity & Systems
Verify data integrity controls per FDA guidance.
- Audit trail enabled on all computerized laboratory systems?
- No deleted, altered, or hidden raw data without documented justification?
- OOS investigation procedure in place and followed per 21 CFR 211.192?
- Reference standards managed with COA, storage, and expiration tracking?
Instruments & Validated Methods
Verify instrument qualification and method validation.
- All lab instruments qualified (IQ/OQ/PQ) per USP <1058>?
- All instruments within calibration interval?
- All test methods validated or verified per ICH Q2(R1)?
- Stability samples stored and tested per stability protocol?
- QC lab compliance notes
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Why Use This Pharmaceutical QC Laboratory Compliance Checklist [FREE PDF]?
This pharmaceutical qc laboratory compliance checklist [free pdf] helps laboratory teams maintain compliance and operational excellence. Designed for qc laboratory manager / quality director professionals, this checklist covers 9 critical inspection points across 2 sections. Recommended frequency: monthly.
Ensures compliance with FDA 21 CFR Part 211 Subpart I (laboratory controls), USP <1058> (analytical instrument qualification), FDA Guidance on Data Integrity and cGMP (2018), ICH Q2(R1) (analytical method validation). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical QC Laboratory Compliance Checklist [FREE PDF] cover?
This checklist covers 9 inspection items across 2 sections: Data Integrity & Systems, Instruments & Validated Methods. It is designed for laboratory operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 30-40 minutes.
Who should use this Pharmaceutical QC Laboratory Compliance Checklist [FREE PDF]?
This checklist is designed for QC Laboratory Manager / Quality Director professionals in the laboratory 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.