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) --- END OF TEMPLATE --- Transform this text into a digital, automated, and trackable mobile app! 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