Pharmaceutical Packaging Materials Audit and Inspection Checklist
Packaging and labeling failures are a leading cause of drug recalls. This audit checklist ensures pharmaceutical packaging materials meet specifications and labeling controls prevent mix-ups per FDA 21 CFR Parts 211.122 and 211.130.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Quarterly
- Estimated Time: 30-45 minutes
- Role: QA Manager / Packaging Development Specialist
- Total Items: 31
- Compliance: FDA 21 CFR 211.122 - Materials Examination and Usage Criteria for Containers, FDA 21 CFR 211.130 - Packaging and Labeling Operations, FDA 21 CFR 211.132 - Tamper-Evident Packaging Requirements for OTC Products, ICH Q1A Stability Testing of Drug Products
Primary Container-Closure System
Inspect primary packaging specification and qualification.
- Container-closure system (CCS) qualified with compatibility and CCI testing?
- Primary packaging materials specifications established and documented?
- Extractables and leachables study completed for primary packaging?
- Plastic containers tested per USP <661> and ICH Q3E if applicable?
- Primary packaging included in ICH stability studies?
Packaging Supplier Controls
Review packaging supplier qualification.
- All primary packaging suppliers on Approved Supplier List?
- Certificate of Analysis received and reviewed for each incoming lot?
- Incoming inspection performed per sampling plan?
- Packaging materials quarantined until QA release?
- Supplier change notification procedure established and working?
Label and Insert Controls
Verify label management and control procedures.
- 100% label reconciliation performed for each batch?
- 100% label verification (100% check or vision system) performed?
- Labels stored in restricted access area?
- Obsolete labels destroyed and documented per procedure?
- Label artwork control procedure with version management in place?
Packaging Operations
Inspect packaging line operations.
- Line clearance completed between batches with documentation?
- Correct packaging materials issued and checked against batch record?
- Tamper-evident packaging applied per 21 CFR 211.132 for applicable OTC products?
- Variable data printing (lot, expiry) verified and documented?
- In-process checks performed at required frequency during packaging?
Stability and Shelf Life
Verify stability program coverage of packaging.
- Ongoing stability program per ICH Q1A with sufficient time points?
- Stability chambers qualified and within calibration?
- Stability data reviewed and no out-of-trend results?
- Expiry dating supported by stability data?
- Post-approval stability commitments met per regulatory filings?
Documentation
Verify packaging documentation compliance.
- Packaging batch record complete with all required entries?
- Retain samples of labeled product from each batch?
- Artwork management procedure with change control in place?
- Traceability system enabling rapid recall notification?
- Electronic batch record validated if used?
- Complete packaging audit report prepared?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Incoming Material Sampling and Testing Checklist
- Pharmaceutical Supplier Qualification Audit Checklist
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist
- GxP Training Compliance and Competency Audit Checklist
- FDA Inspection Readiness Assessment Checklist
- Pharmaceutical Product Recall Readiness Checklist
- FDA GMP Inspection Readiness Audit Checklist
Related Supply Chain Checklists
- Pharmaceutical Supplier Qualification Audit Checklist - FREE Download
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist - FREE Download
- Pharmaceutical Incoming Material Sampling and Testing Checklist - FREE Download
Why Use This Pharmaceutical Packaging Materials Audit and Inspection Checklist?
This pharmaceutical packaging materials audit and inspection checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / packaging development specialist professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: quarterly.
Ensures compliance with FDA 21 CFR 211.122 - Materials Examination and Usage Criteria for Containers, FDA 21 CFR 211.130 - Packaging and Labeling Operations, FDA 21 CFR 211.132 - Tamper-Evident Packaging Requirements for OTC Products, ICH Q1A Stability Testing of Drug Products. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Packaging Materials Audit and Inspection Checklist cover?
This checklist covers 31 inspection items across 6 sections: Primary Container-Closure System, Packaging Supplier Controls, Label and Insert Controls, Packaging Operations, Stability and Shelf Life, 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 30-45 minutes.
Who should use this Pharmaceutical Packaging Materials Audit and Inspection Checklist?
This checklist is designed for QA Manager / Packaging Development Specialist 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.