Pharmaceutical Vendor Qualification Checklist

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 --- END OF TEMPLATE --- Transform this text into a digital, automated, and trackable mobile app! Visit: https://checklistguro.com/templates/pharmaceutical/pharmaceutical-vendor-qualification-checklist (Click "Install Template" to launch your digital inspection tool immediately)