ChecklistGuro GxP Pharmaceutical Audit Checklist
Ensure GxP compliance with our comprehensive Pharmaceutical Audit Checklist. Streamline your audits, identify critical gaps, and maintain regulatory readiness with this essential tool for pharmaceutical quality management.
This Template was installed 1 times.
Scope & Planning
Review of audit scope, objectives, and planning activities.
Audit Start Date
Audit End Date
Audit Team Size
Audit Type
Audit Objectives & Scope Description
Areas to be Audited (Select all that apply)
Auditee Contact Person
Personnel & Training
Assessment of personnel qualifications, training records, and competency.
Employee ID
Job Title
Date of Last Training (GxP)
Training Status
Training Summary/Description
Training Certificates/Records
Qualified for Critical Roles?
Standard Operating Procedures (SOPs)
Verification of SOP existence, review, approval, and adherence.
SOP Review Frequency
Last SOP Review Date
SOP Approval Status
Comments Regarding SOP Review (if applicable)
Reviewer Signature
SOP Revision Number
Upload of Updated SOP Document
Facilities & Equipment
Evaluation of facility design, maintenance, calibration, and equipment suitability.
Area/Room Audited
Equipment Serial Number
Last Calibration Date
Temperature at Time of Audit
Temperature Range (validated)
Equipment Status
Observations/Comments on Facility/Equipment Condition
Supporting Documentation (e.g., Calibration Certificates)
Materials Management
Assessment of raw material sourcing, testing, storage, and handling.
Batch Number
Date of Receipt
Quantity Received
Supplier
Supplier CoA Review Comments
Material Status Upon Receipt
Quarantine Reason (if applicable)
Supplier CoA
Manufacturing Processes
Review of manufacturing steps, in-process controls, and documentation.
Batch Number
Start Date of Manufacturing
Start Time of Manufacturing
Manufacturing Process Narrative - Briefly describe deviations from SOP
Equipment Used (Select all that apply)
Weight of Material Added (kg)
Appearance of Product (Select one)
Operator Signature
Laboratory Controls
Evaluation of testing methods, data integrity, and analytical equipment.
Equipment Calibration Frequency (Months)
Last Calibration Date
Summary of Calibration Results/Deviations
Method Validation Status
Method Validation Report (if applicable)
Number of Out-of-Specification (OOS) Results
Description of OOS Investigation (if applicable)
Data Integrity Controls in Place?
Documentation & Records
Verification of record-keeping practices, data integrity, and traceability.
Document Number
Document Creation Date
Document Review Date
Document Status (Approved/Revoked/Obsolete)
Document Revision History (brief summary)
Upload Document (PDF/Word)
Number of copies distributed
Reviewer Signature
Change Control
Assessment of change management processes and impact assessments.
Change Control Number
Date of Change Request
Description of Proposed Change
Change Category (e.g., Equipment, Process, SOP)
Rationale for Change
Estimated Implementation Time (Days)
Risk Assessment Level (Low, Medium, High)
Requestor Signature
Deviations & CAPA
Review of deviation management, corrective and preventive actions.
Deviation Number
Date of Deviation
Detailed Description of Deviation
Deviation Severity (e.g., Minor, Moderate, Major)
Root Cause Analysis
Corrective Action Plan
Corrective Action Due Date
Effectiveness Check / Verification Results
CAPA Status
CAPA Reviewer Signature
Complaints & Recalls
Evaluation of complaint handling and recall procedures.
Complaint/Recall Number
Date of Complaint/Recall Initiation
Detailed Description of Complaint/Recall Event
Product Affected
Severity Level
Root Cause Categories (if known)
Supporting Documentation (e.g., batch records, lab reports)
Target Completion Date for Corrective Action
Vendor Management
Assessment of vendor qualification and oversight.
Vendor Risk Level
Vendor Qualification Date
Vendor Qualification Rationale
Vendor Audit Report
Number of Audits Conducted
Vendor Status
Summary of Last Audit Findings
Data Integrity
Verification of data integrity controls (ALCOA principles).
ALCOA-C Principle Compliance: Source
Audit Trail Enabled?
Number of Data Integrity Events Identified (if any)
Description of Identified Data Integrity Risks or Concerns
Data Integrity Controls Implemented (Select all that apply)
Last Data Integrity Training Completion Date
Are User Access Rights Reviewed Periodically?
Closing & Reporting
Review of audit findings, report preparation, and follow-up actions.
Audit Completion Date
Audit Completion Time
Summary of Key Findings
Number of Major Observations
Number of Minor Observations
Overall Audit Rating
Lead Auditor Signature
Supporting Documentation (e.g., Photo Evidence)
Frequently Asked Questions
Can I customize this template after installing it?
Absolutely. Once installed, you can add, remove, or reorder tasks, add custom fields, and adjust deadlines to fit your specific workflow.
Can I add images or photos to these checklist items?
Yes. Our platform allows you to attach photos, signatures, and notes to any checklist item for better verification and proof of completion.
Can I create a custom checklist from scratch instead of using a template?
Yes. You can use our "Create your own checklist" feature to build a unique workflow tailored exactly to your operational requirements.
Can I add dependencies between tasks?
Yes, you can set up conditional logic and dependencies to ensure your team follows the correct sequence of operations.
Can I assign specific checklist items to different team members?
Yes. You can assign individual tasks to specific employees, ensuring clear accountability across your entire team.
Can I use these checklists on mobile devices in the field?
Yes. Our platform is fully responsive, allowing your team to complete, update, and upload photos to checklists directly from any smartphone or tablet.
How do I notify my manager when a checklist is completed?
You can set up automated notifications (via email, push notification, or in-app alerts) to trigger whenever a checklist is finished or if an item fails inspection.
Can multiple people work on the same checklist simultaneously?
Yes, the platform supports real-time updates, allowing multiple users to contribute to a single live checklist.
Where is the data from completed checklists stored?
All completed checklists are stored securely in your Work OS dashboard, creating a permanent, searchable audit trail of your operations.
Can I generate reports based on my checklist results?
Yes. You can track completion rates, identify recurring issues, and monitor team performance through our integrated reporting and analytics tools.
How can I use these checklists for compliance or auditing purposes?
Because our checklists capture timestamps, photos, and digital signatures, they serve as a robust digital paper trail for regulatory compliance and internal audits.
Can I export my completed checklist data for use in other tools?
Yes. You can export your data in various formats (CSV, Excel, etc.) to integrate your operational insights with your other business software.
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