Pharmaceutical BOM Traceability Checklist
Ensure regulatory compliance and product integrity with our Pharmaceutical BOM Traceability Checklist. Simplify complex supply chain management, track every component, and maintain a complete audit trail - all within our powerful BPM platform. Download now and streamline your BOM processes!
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Component Identification & Sourcing
Verifies accurate component identification, supplier information, and associated documentation.
Component Part Number
Component Description
Component Classification (e.g., Raw Material, Sub-Assembly)
Supplier Status (Approved, Pending Approval, Unapproved)
Supplier Part Number
Supplier Name
Quantity per BOM
Supplier Data Sheet (Optional)
Lot & Serial Number Tracking
Ensures robust lot and serial number tracking for all components and materials.
Component Lot Number
Component Serial Number (if applicable)
Quantity Received
Date of Receipt
Receiving Notes/Observations
Supplier Lot Number
Lot Status
Supporting Documentation (e.g., Receiving Record)
Supplier Qualification & Audits
Confirms supplier qualification status and records of audits performed.
Supplier Qualification Status
Initial Qualification Date
Last Audit Date
Audit Score (e.g., 1-100)
Key Findings from Last Audit
Audit Report (PDF)
Corrective Action Plan Status
Summary of Supplier CAPA (Corrective Action Preventive Action)
Material Certificates & Testing
Validates receipt and retention of material certificates (e.g., CoA) and testing results.
Certificate of Analysis (CoA) - Primary Material
Certificate of Analysis (CoA) - Secondary Material (if applicable)
CoA Revision Number
CoA Issue Date
Summary of Testing Parameters (per CoA)
Testing Performed (Select all that apply)
Specify 'Other' Testing (if selected above)
Result Threshold/Specification Limit
CoA Status
Change Control & Approvals
Documents change control processes related to BOM revisions and component substitutions.
Date of Change Request
Description of Change
Change Category (e.g., Component, Supplier, Specification)
Revision Number (Pre-Change)
Revision Number (Post-Change)
Affected BOM(s)
Requestor Signature
Reason for Change
Documentation & Record Keeping
Confirms adequate documentation of all traceability activities and record retention policies.
Document Creation Date
Last Review Date
Summary of Record Keeping Procedures
Number of Copies Maintained
Record Storage Location
Sample Record Documentation (e.g., CoA, Supplier Audit Report)
Record Keeper Signature
Time of Record Update
Deviation Reporting & Investigation
Verifies procedures for reporting and investigating deviations from established traceability standards.
Description of Deviation
Date of Deviation
Time of Deviation
Deviation Category (e.g., Material, Process, Documentation)
Quantity Affected (if applicable)
Related Components/Materials Affected (Select all that apply)
Root Cause Analysis Findings
Corrective Actions Taken
Date Corrective Actions Implemented
Signature of Investigator
Regulatory Compliance & Validation
Ensures compliance with relevant regulatory requirements (e.g., FDA, EMA) and validation of traceability system.
Applicable Regulations (e.g., FDA 21 CFR Part 11, EU GMP)
Specification of 'Other' Regulations (If Selected Above)
Date of Last Regulatory Audit
Audit Score (if applicable)
Summary of Audit Findings and Corrective Actions
Copy of Latest Regulatory Audit Report
Validation Status of Traceability System
Date of Last Validation/Revalidation
Training & Competency
Confirms adequate training and competency of personnel involved in BOM management and traceability.
Number of Employees Trained on BOM Traceability
Training Delivery Method (e.g., Classroom, Online, Hybrid)
Date of Last Training Refresher
Brief Description of Training Curriculum
Level of Training Certification Required (if applicable)
Upload Training Records/Certificates (optional)
System Integration & Data Integrity
Evaluates the integrity of data across integrated systems and ensures data is accurate and accessible.
Number of Integrated Systems
Data Synchronization Method
Last Data Integrity Audit Date
Description of Data Validation Checks Performed
Data Backup Frequency
Data Flow Diagrams (if applicable)
Number of Data Breaches/Integrity Incidents (past year)
Bill of Materials (BOM) Screen Recording
Learn how to manage and utilize Bills of Materials (BOMs) within ChecklistGuro, our powerful Business Process Management (BPM) platform! This screen recording demonstrates how to create, edit, and view BOMs, linking them to your tasks and workflows. Optimize your manufacturing, assembly, and production processes with ChecklistGuro.
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