Document no.
: AE SOP-QA-007
Revision no.: 00 Page 1 of 5
Document Title: SOP SELF-INSPECTION PROGRAM
1. PURPOSE
To establish a system for conducting periodic self-inspections to verify compliance with FDA Good
Distribution Practices (GDP), company procedures, and applicable regulatory requirements, and to
identify opportunities for continuous improvement.
2. SCOPE
This procedure applies to all activities and areas of Alpha-Era Pharmaceutical Products Distribution,
including:
• Quality Management System
• Personnel
• Documentation
• Receiving Operations
• Storage Areas
• Dispatch Operations
• Temperature Monitoring
• Complaint Handling
• Product Recall
• Returned Products
• Quarantine Area
• Housekeeping and Sanitation
• Pest Control
• Vehicle Operations
• Training Records
3. RESPONSIBILITIES
Pharmacist (Self-Inspection Coordinator)
• Plan and conduct self-inspections.
• Prepare inspection reports.
• Monitor corrective actions.
Manager
• Review findings.
• Approve corrective actions.
• Ensure timely closure of observations.
All Personnel
• Cooperate during inspections.
• Implement corrective actions when assigned.
4. PROCEDURE
4.1 Inspection Frequency
Self-inspections shall be conducted:
Prepared by: Annabelita A. Caminade Reviewed by: Elvijean V. Estenzo
Document no.: AE SOP-QA-007
Revision no.: 00 Page 2 of 5
Document Title: SOP SELF-INSPECTION PROGRAM
✔ At least once every six (6) months
✔ Prior to FDA inspections
✔ After major operational changes
✔ When significant deviations occur
4.2 Inspection Planning
The Pharmacist shall prepare:
• Self-Inspection Schedule
• Inspection Checklist
• Previous CAPA Review
4.3 Conduct of Self-Inspection
The inspection shall include verification of:
Personnel
• Training records available
• Job descriptions available
• Personnel competency maintained
Documentation
• SOPs approved and current
• Forms properly completed
• Records legible and available
Receiving Operations
• Receiving records complete
• Product inspection performed
• Supplier verification conducted
Storage Area
• Clean and organized
• FEFO implemented
• Products off the floor
• Temperature maintained
Quarantine Area
• Properly labeled
• Segregated products
• Access controlled
Temperature Monitoring
• Records complete
• Monitoring performed as scheduled
• Excursions investigated
Complaint Handling
Prepared by: Annabelita A. Caminade Reviewed by: Elvijean V. Estenzo
Document no.: AE SOP-QA-007
Revision no.: 00 Page 3 of 5
Document Title: SOP SELF-INSPECTION PROGRAM
• Complaint records available
• Investigations completed
Product Recall
• Recall procedure available
• Recall records maintained
Housekeeping
• Facility clean
• Cleaning records maintained
Pest Control
• Pest monitoring records maintained
• Pest map updated
Vehicle Operations
• Cleaning records available
• Maintenance records available
4.4 Classification of Findings
Critical
Deficiencies that may affect product quality, safety, or regulatory compliance.
Major
Significant deficiencies requiring corrective action.
Minor
Observations requiring improvement but not immediately affecting quality.
4.5 Corrective and Preventive Action (CAPA)
For each finding:
1. Determine root cause.
2. Establish corrective action.
3. Assign responsible personnel.
Prepared by: Annabelita A. Caminade Reviewed by: Elvijean V. Estenzo
Document no.: AE SOP-QA-007
Revision no.: 00 Page 4 of 5
Document Title: SOP SELF-INSPECTION PROGRAM
4. Establish target completion date.
5. Verify effectiveness.
4.6 Follow-Up
The Pharmacist shall verify completion of corrective actions and document closure of findings.
5. RECORDS GENERATED
• Self-Inspection Schedule
• Self-Inspection Checklist
• Self-Inspection Report
• CAPA Report
• Follow-Up Verification Report
ATTACHMENT 1
Self-Inspection Checklist
Area Yes No N/A Remarks
SOPs approved and current ☐ ☐ ☐
Training records available ☐ ☐ ☐
Receiving records complete ☐ ☐ ☐
Dispatch records complete ☐ ☐ ☐
Temperature logs updated ☐ ☐ ☐
Quarantine area identified ☐ ☐ ☐
Complaint log maintained ☐ ☐ ☐
Recall records maintained ☐ ☐ ☐
Housekeeping records available ☐ ☐ ☐
Pest control records available ☐ ☐ ☐
Prepared by: Annabelita A. Caminade Reviewed by: Elvijean V. Estenzo
Document no.: AE SOP-QA-007
Revision no.: 00 Page 5 of 5
Document Title: SOP SELF-INSPECTION PROGRAM
Area Yes No N/A Remarks
Vehicle maintenance records available ☐ ☐ ☐
Facility clean and organized ☐ ☐ ☐
Inspector: ______________________
Date: ______________________
ATTACHMENT 2
Self-Inspection Report
Inspection Date: __________________
Inspector: __________________
Findings
No. Area Observation Classification
1 Critical / Major / Minor
2 Critical / Major / Minor
Recommendations
Inspector Signature: __________________
Manager Signature: __________________
ATTACHMENT 3
CAPA Tracking Log
Finding No. Observation Corrective Action Responsible Person Due Date Status
Prepared by: Annabelita A. Caminade Reviewed by: Elvijean V. Estenzo