PHARMACEUTICAL VENDOR QUALIFICATION CHECKLIST

Created by ChecklistGuro (https://checklistguro.com)

--- VENDOR INFORMATION & INITIAL ASSESSMENT ---
[ ] Vendor Legal Name
[ ] Vendor Contact Person
[ ] Vendor Address
[ ] Years in Business
[ ] Primary Business Type (Raw Materials, Packaging, Equipment, Services, Other)
[ ] Initial Risk Assessment Level (Low, Medium, High)
[ ] Initial Assessment Date

--- FINANCIAL STABILITY & BUSINESS PRACTICES ---
[ ] Annual Revenue (USD)
[ ] Debt-to-Equity Ratio
[ ] Credit Rating Agency (Moody's, Standard & Poor's, Fitch, Not Rated)
[ ] Summary of Financial Stability Assessment
[ ] Business Ethics Program (Yes, documented program, Yes, informal policy, No program in place)
[ ] Date of Last Financial Review

--- QUALITY MANAGEMENT SYSTEM (QMS) ---
[ ] QMS Documentation Availability (Complete & Current, Partially Available, Not Available)
[ ] Summary of QMS Documentation Reviewed
[ ] Number of Documented Procedures
[ ] Date of Last QMS Audit
[ ] QMS Elements Assessed (Select all that apply) (Document Control, CAPA, Change Management, Training, Internal Audits, Management Review)
[ ] Copy of QMS Manual (if available)
[ ] Evidence of Management Review (Yes, No, Not Applicable)

--- FACILITY & EQUIPMENT ---
[ ] Facility Address
[ ] Square Footage of Manufacturing Area
[ ] Equipment Types Present (Select all that apply) (Reactors, Dryers, Mills, Filters, Packaging Equipment, Analytical Instruments)
[ ] Last Facility Inspection Date
[ ] Facility Layout Diagram
[ ] HVAC System Temperature Control Range
[ ] Description of Cleaning and Sanitation Procedures

--- PERSONNEL & TRAINING ---
[ ] Number of Qualified Personnel
[ ] Key Personnel Qualifications (e.g., GMP, Degree) (GMP Training, Relevant Degree, Other)
[ ] Last Training Completion Date (Key Personnel)
[ ] Brief Description of Key Personnel Training Program
[ ] Training Records (Example)
[ ] Verification of Personnel Background Checks (Yes, No, N/A)
[ ] Details on Background Check Procedures (if applicable)

--- REGULATORY COMPLIANCE & AUDITS ---
[ ] Last Audit Score
[ ] Date of Last Regulatory Inspection
[ ] Summary of Findings from Last Regulatory Inspection
[ ] Compliance with GMP Guidelines? (Yes, No, N/A)
[ ] Relevant Regulatory Frameworks (Select all that apply) (FDA, EMA, WHO, PIC/S, Other)
[ ] Copy of Latest Regulatory Audit Report

--- PRODUCT/SERVICE SPECIFICATIONS & TESTING ---
[ ] Detailed Product/Service Specifications
[ ] Testing Methodology Alignment (e.g., USP, EP, JP) (USP, EP, JP, Other (Specify))
[ ] Acceptance Criteria Limit (e.g., Purity %)
[ ] Certificate of Analysis (CoA)
[ ] CoA Issue Date
[ ] Testing Parameters Verified (Select all that apply) (Identity, Purity, Assay, Impurities, Water Content, Other (Specify))
[ ] Deviations & Resolutions (if any)

--- CHANGE CONTROL & CORRECTIVE ACTIONS ---
[ ] Change Request Originated From: (Quality Assurance, Manufacturing, Engineering, Regulatory Affairs, Other)
[ ] Description of Change/Deviation
[ ] Risk Score (assigned)
[ ] Date of Deviation/Change Initiation
[ ] Root Cause Analysis Findings
[ ] Potential Impact Areas (select all that apply) (Manufacturing Process, Product Quality, Equipment, Documentation, Regulatory Compliance)
[ ] Corrective Actions Planned
[ ] Planned Completion Date of Corrective Actions
[ ] Signature of Responsible Person

--- CONTRACTUAL AGREEMENTS & PERFORMANCE MONITORING ---
[ ] Contract Start Date
[ ] Contract Expiration Date
[ ] Agreed Upon Price/Rate
[ ] Payment Terms (Net 30, Net 60, Other (Specify))
[ ] Key Performance Indicators (KPIs)
[ ] Performance Rating (Scale 1-5)
[ ] Performance Review Comments
[ ] Contract Renewed? (Yes, No)

--- REQUALIFICATION & PERIODIC REVIEW ---
[ ] Last Requalification Date
[ ] Review Frequency (in months)
[ ] Review Type (Document Review, On-site Audit, Combination)
[ ] Summary of Review Findings
[ ] Reviewer Signature
[ ] Next Review Date

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