GXP PHARMACEUTICAL AUDIT CHECKLIST

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

--- SCOPE & PLANNING ---
[ ] Audit Start Date
[ ] Audit End Date
[ ] Audit Team Size
[ ] Audit Type (Routine, For Cause, Follow-up)
[ ] Audit Objectives & Scope Description
[ ] Areas to be Audited (Select all that apply) (Manufacturing, Quality Control, Warehouse, Document Control)
[ ] Auditee Contact Person

--- PERSONNEL & TRAINING ---
[ ] Employee ID
[ ] Job Title (Quality Assurance, Manufacturing, Laboratory, Maintenance, Other)
[ ] Date of Last Training (GxP)
[ ] Training Status (Completed, In Progress, Not Started)
[ ] Training Summary/Description
[ ] Training Certificates/Records
[ ] Qualified for Critical Roles? (Yes, No, N/A)

--- STANDARD OPERATING PROCEDURES (SOPS) ---
[ ] SOP Review Frequency (Annual, Bi-Annual, As Needed)
[ ] Last SOP Review Date
[ ] SOP Approval Status (Approved, Pending Approval, Rejected)
[ ] Comments Regarding SOP Review (if applicable)
[ ] Reviewer Signature
[ ] SOP Revision Number
[ ] Upload of Updated SOP Document

--- FACILITIES & EQUIPMENT ---
[ ] Area/Room Audited
[ ] Equipment Serial Number
[ ] Last Calibration Date
[ ] Temperature at Time of Audit
[ ] Temperature Range (validated)
[ ] Equipment Status (Operational, Out of Service, Under Maintenance)
[ ] Observations/Comments on Facility/Equipment Condition
[ ] Supporting Documentation (e.g., Calibration Certificates)

--- MATERIALS MANAGEMENT ---
[ ] Batch Number
[ ] Date of Receipt
[ ] Quantity Received
[ ] Supplier (Supplier A, Supplier B, Supplier C)
[ ] Supplier CoA Review Comments
[ ] Material Status Upon Receipt (Acceptable, Quarantine, Rejected)
[ ] Quarantine Reason (if applicable)
[ ] Supplier CoA

--- MANUFACTURING PROCESSES ---
[ ] Batch Number
[ ] Start Date of Manufacturing
[ ] Start Time of Manufacturing
[ ] Manufacturing Process Narrative - Briefly describe deviations from SOP
[ ] Equipment Used (Select all that apply) (Mixer, Granulator, Tablet Press, Capsule Filling Machine, Dryer, Coater)
[ ] Weight of Material Added (kg)
[ ] Appearance of Product (Select one) (Correct, Slightly Off, Significant Deviation)
[ ] Operator Signature

--- LABORATORY CONTROLS ---
[ ] Equipment Calibration Frequency (Months)
[ ] Last Calibration Date
[ ] Summary of Calibration Results/Deviations
[ ] Method Validation Status (Validated, Not Validated, Validation Expiration Approaching)
[ ] Method Validation Report (if applicable)
[ ] Number of Out-of-Specification (OOS) Results
[ ] Description of OOS Investigation (if applicable)
[ ] Data Integrity Controls in Place? (Yes, No, Not Applicable)

--- DOCUMENTATION & RECORDS ---
[ ] Document Number
[ ] Document Creation Date
[ ] Document Review Date
[ ] Document Status (Approved/Revoked/Obsolete) (Approved, Revoked, Obsolete)
[ ] Document Revision History (brief summary)
[ ] Upload Document (PDF/Word)
[ ] Number of copies distributed
[ ] Reviewer Signature

--- CHANGE CONTROL ---
[ ] Change Control Number
[ ] Date of Change Request
[ ] Description of Proposed Change
[ ] Change Category (e.g., Equipment, Process, SOP) (Equipment, Process, SOP, Material, Facility)
[ ] Rationale for Change
[ ] Estimated Implementation Time (Days)
[ ] Risk Assessment Level (Low, Medium, High) (Low, Medium, High)
[ ] Requestor Signature

--- DEVIATIONS & CAPA ---
[ ] Deviation Number
[ ] Date of Deviation
[ ] Detailed Description of Deviation
[ ] Deviation Severity (e.g., Minor, Moderate, Major) (Minor, Moderate, Major)
[ ] Root Cause Analysis
[ ] Corrective Action Plan
[ ] Corrective Action Due Date
[ ] Effectiveness Check / Verification Results
[ ] CAPA Status (Open, In Progress, Closed)
[ ] CAPA Reviewer Signature

--- COMPLAINTS & RECALLS ---
[ ] Complaint/Recall Number
[ ] Date of Complaint/Recall Initiation
[ ] Detailed Description of Complaint/Recall Event
[ ] Product Affected (Drug Product, Active Pharmaceutical Ingredient (API), Excipient)
[ ] Severity Level (Critical, Serious, Moderate, Minor)
[ ] Root Cause Categories (if known) (Equipment Failure, Process Deviation, Personnel Error, Supplier Issue, Packaging Defect)
[ ] Supporting Documentation (e.g., batch records, lab reports)
[ ] Target Completion Date for Corrective Action

--- VENDOR MANAGEMENT ---
[ ] Vendor Risk Level (Low, Medium, High)
[ ] Vendor Qualification Date
[ ] Vendor Qualification Rationale
[ ] Vendor Audit Report
[ ] Number of Audits Conducted
[ ] Vendor Status (Approved, Suspended, Rejected)
[ ] Summary of Last Audit Findings

--- DATA INTEGRITY ---
[ ] ALCOA-C Principle Compliance: Source (Documented, Electronic System, Both)
[ ] Audit Trail Enabled? (Yes, No, N/A)
[ ] Number of Data Integrity Events Identified (if any)
[ ] Description of Identified Data Integrity Risks or Concerns
[ ] Data Integrity Controls Implemented (Select all that apply) (Access Controls, Audit Trails, Data Encryption, Change Control, Training Records, Validation of Computerized Systems)
[ ] Last Data Integrity Training Completion Date
[ ] Are User Access Rights Reviewed Periodically? (Yes, No, N/A)

--- CLOSING & REPORTING ---
[ ] Audit Completion Date
[ ] Audit Completion Time
[ ] Summary of Key Findings
[ ] Number of Major Observations
[ ] Number of Minor Observations
[ ] Overall Audit Rating (Acceptable, Requires Improvement, Unsatisfactory)
[ ] Lead Auditor Signature
[ ] Supporting Documentation (e.g., Photo Evidence)

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