Pharmaceutical Incoming Material Sampling and Testing Checklist
Incoming material controls are the first line of defense against substandard or adulterated components. This checklist ensures receipt, sampling, and testing of incoming materials comply with FDA 21 CFR 211.84 requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Per Incoming Shipment
- Estimated Time: 20-30 minutes
- Role: Warehouse Supervisor / QC Analyst
- Total Items: 31
- Compliance: FDA 21 CFR 211.84 - Testing and Approval or Rejection of Components, FDA 21 CFR 211.86 - Use of Approved Components, USP <1> Injections and Implanted Drug Products - Container Testing, ICH Q10 Section 3.4 Purchased Materials
Shipment Documentation Review
Verify shipment documentation.
- Material matches purchase order - correct material, supplier, and quantity?
- Certificate of Analysis (CoA) provided with shipment?
- CoA specifications reviewed and match approved specifications?
- Supplier on current Approved Supplier List?
- Shipping manifest or bill of lading on file?
Physical Container Inspection
Inspect containers for damage or tamper evidence.
- All containers intact with no damage, dents, or leaks?
- Tamper-evident seals intact on all containers?
- All container labels legible and complete?
- Quantity received matches purchase order?
- Temperature monitor reviewed if cold chain required?
Quarantine and Sampling
Place material in quarantine and sample per plan.
- All containers labeled with quarantine status label?
- Material stored in designated quarantine area per storage conditions?
- Sampling performed per approved sampling plan (ANSI/ASQ Z1.4 or site SOP)?
- Samples labeled with material name, lot, date, and sampler?
- Samples submitted to QC laboratory with chain of custody?
Identity Testing
Verify identity testing is performed.
- Identity test (IR, HPLC, NIR, wet chemical) performed on each received lot?
- Identity test result confirmed correct material?
- Vendor CoA results compared to site specification limits?
- Full testing per specifications determined for this material and supplier qualification level?
- Skip lot testing justified based on validated supplier qualification history?
Release or Rejection
Document material release or rejection.
- All required testing complete with passing results?
- QA release authorization obtained before moving material to approved stock?
- Quarantine labels replaced with approved labels after release?
- OOS investigation initiated for any failing test result?
- Rejected material documented with rejection reason and disposition?
Documentation
Complete incoming material records.
- Receiving log updated with all shipment details?
- Supplier CoA filed in material receiving records?
- Sample receipt record on file in QC laboratory?
- Inventory system updated with receipt, lot, and status?
- Non-conformance report initiated for any discrepancies found?
- All receiving records retained per document retention schedule?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Supplier Qualification Audit Checklist
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist
- Pharmaceutical Packaging Materials Audit and Inspection Checklist
- FDA GMP Inspection Readiness Audit Checklist
- Annual Product Quality Review (APQR) Preparation Checklist
- Pharmaceutical Product Complaint Handling Checklist
- Pharmaceutical Cleanroom Environmental Monitoring Checklist
Related Supply Chain Checklists
- Pharmaceutical Supplier Qualification Audit Checklist - FREE Download
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist - FREE Download
- Pharmaceutical Packaging Materials Audit and Inspection Checklist - FREE Download
Why Use This Pharmaceutical Incoming Material Sampling and Testing Checklist?
This pharmaceutical incoming material sampling and testing checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for warehouse supervisor / qc analyst professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: per incoming shipment.
Ensures compliance with FDA 21 CFR 211.84 - Testing and Approval or Rejection of Components, FDA 21 CFR 211.86 - Use of Approved Components, USP <1> Injections and Implanted Drug Products - Container Testing, ICH Q10 Section 3.4 Purchased Materials. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Incoming Material Sampling and Testing Checklist cover?
This checklist covers 31 inspection items across 6 sections: Shipment Documentation Review, Physical Container Inspection, Quarantine and Sampling, Identity Testing, Release or Rejection, Documentation. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed per incoming shipment. Each completion takes approximately 20-30 minutes.
Who should use this Pharmaceutical Incoming Material Sampling and Testing Checklist?
This checklist is designed for Warehouse Supervisor / QC Analyst 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.