Good Manufacturing Practice GMP Audit Checklist

Here’s a comprehensive GMP Audit Checklist template for use with eAuditor Audits & Inspections, customizable based on your facility’s specific requirements:

GMP Audit Checklist Template (eAuditor Audits & Inspections)

1. General Information:

• Audit Date: [Date Picker]
• Auditor Name: [Text Field]
• Facility Name/Location: [Text Field]
• Department: [Text Field]
• Type of Audit: [Dropdown: Internal, External, Routine, Follow-up]

2. Personnel:

Personnel Hygiene:

• Are employees wearing appropriate PPE (gloves, masks, hairnets, etc.)? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]
• Are handwashing facilities available and used properly? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]
• Are employees following proper hygiene protocols (no eating/drinking in production areas)? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]

Training and Competency:

• Are employees adequately trained in GMP procedures? [Yes/No/NA]
  • Training Records Available: [Yes/No/NA]
  • Notes: [Text Field]
• Are records of employee training up to date? [Yes/No/NA]
  • Notes: [Text Field]

3. Facility and Equipment:

Facility Cleanliness and Maintenance:

• Is the facility clean and free from contamination sources (dust, spills, pests)? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]
• Are floors, walls, and ceilings in good condition (no cracks, holes, or leaks)? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]
• Is there a pest control system in place and regularly maintained? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]

Equipment Inspection and Maintenance:

• Is equipment clean, properly maintained, and calibrated? [Yes/No/NA]
  • Calibration Records Available: [Yes/No/NA]
  • Attach Photos: [Attach Photo Field]
• Is equipment stored properly when not in use? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]
• Are cleaning and sanitation schedules followed? [Yes/No/NA]
  • Sanitation Logs Available: [Yes/No/NA]
  • Notes: [Text Field]

4. Documentation and Record Keeping:

Batch Records:

• Are batch records complete, accurate, and up to date? [Yes/No/NA]
  • Attach Example Records: [Attach File]
• Do batch records include all required details (lot numbers, dates, signatures)? [Yes/No/NA]
  • Notes: [Text Field]

Standard Operating Procedures (SOPs):

• Are SOPs for all critical operations (cleaning, manufacturing, packaging) available? [Yes/No/NA]
  • SOPs Easily Accessible: [Yes/No/NA]
  • Notes: [Text Field]
• Are SOPs followed by staff during operations? [Yes/No/NA]
  • Notes: [Text Field]

5. Raw Materials and Storage:

Raw Material Handling:

• Are raw materials stored in appropriate conditions (temperature, humidity)? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]
• Are raw materials labeled with batch numbers and expiry dates? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]

Inventory Control:

• Is there an effective inventory control system in place? [Yes/No/NA]
  • FIFO (First In, First Out) Procedure Followed: [Yes/No/NA]
  • Notes: [Text Field]
• Are expired or rejected materials properly handled and segregated? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]

6. Production Process:

Process Control:

• Are all production processes monitored and controlled as per GMP guidelines? [Yes/No/NA]
  • Notes: [Text Field]
• Is there a record of critical control points (CCPs) in the manufacturing process? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach CCP Records: [Attach File]

Product Quality and Testing:

• Are products tested regularly for quality and safety (microbiological, physical, chemical testing)? [Yes/No/NA]
  • Testing Logs Available: [Yes/No/NA]
  • Attach Photos: [Attach Photo Field]
• Are deviations from specifications properly documented and addressed? [Yes/No/NA]
  • Notes: [Text Field]

7. Packaging and Labeling:

• Is packaging material stored in a clean and secure environment? [Yes/No/NA]
  • Notes: [Text Field]
• Are labels clear, legible, and accurate (including expiry dates, batch numbers, ingredients)? [Yes/No/NA]
  • Notes: [Text Field]
  • Attach Photos: [Attach Photo Field]

8. Cleaning and Sanitation:

• Are cleaning agents and sanitizers approved for use in food/drug manufacturing? [Yes/No/NA]
  • Notes: [Text Field]
• Are cleaning logs maintained and up to date? [Yes/No/NA]
  • Attach Logs: [Attach File]
• Are waste disposal procedures followed? [Yes/No/NA]
  • Notes: [Text Field]

9. Quality Control and Assurance:

• Is there a QA/QC department in place to monitor GMP compliance? [Yes/No/NA]
  • Notes: [Text Field]
• Is there a system in place for handling product complaints and recalls? [Yes/No/NA]
  • Notes: [Text Field]

10. Conclusion and Action Plan:

Audit Summary:

• Overall GMP Compliance: [Dropdown: Compliant, Minor Non-Compliance, Major Non-Compliance, Critical Non-Compliance]
  • Notes: [Text Field]

Action Items:

• List of Corrective Actions Needed: [Text Field]
  • Responsible Person: [Text Field]
  • Target Completion Date: [Date Picker]

11. Signatures:

• Auditor Signature: [Digital Signature Field]
• Facility Representative Signature: [Digital Signature Field]

How to Use eAuditor Audits & Inspections for GMP Audits:

1. Create the GMP Audit Checklist Template: Input the checklist items into eAuditor Audits & Inspections, using dropdowns, text fields, and photo attachment options as needed.
2. Audit Real-Time: Conduct audits using a tablet or smartphone, with photos, notes, and digital signatures added on the spot.
3. Generate Reports: Automatically generate detailed reports summarizing the audit findings and action items.
4. Assign Actions: Assign corrective actions to team members with deadlines for follow-up.
5. Schedule Regular Audits: Use eAuditor Audits & Inspections to schedule recurring GMP audits to maintain ongoing compliance.

This checklist ensures that your GMP audit covers all critical aspects of manufacturing compliance, from personnel hygiene to record-keeping and facility maintenance.