Perform GMP (Good Manufacturing Practice) Audit using eAuditor
A GMP (Good Manufacturing Practice) Audit is a systematic inspection and evaluation process carried out to verify whether a manufacturing facility, its processes, and personnel comply with established Good Manufacturing Practice standards. These standards are regulatory guidelines that ensure products—particularly pharmaceuticals, food, cosmetics, and medical devices—are consistently produced and controlled according to quality and safety requirements.
Performinga GMP (Good Manufacturing Practice) Audit using eAuditor ensures a structured evaluation of manufacturing facilities, processes, and personnel practices to verify compliance with GMP standards while safeguarding product quality, safety, and regulatory adherence. By digitizing the audit process, organizations can streamline inspections, capture real-time evidence, assign corrective actions, and generate comprehensive reports for continuous improvement.
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Purpose of the GMP Audit
The primary goals of conducting a GMP Audit with eAuditor are to:
- Verify adherence to international GMP standards (FDA, WHO, EU GMP, or local regulations).
- Ensure manufacturing processes consistently produce safe and high-quality products.
- Detect non-conformities in facilities, equipment, personnel, and documentation.
- Support corrective and preventive action (CAPA) planning and risk management.
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Scope of the Audit
A GMP Audit with eAuditor typically covers:
- Facility and environment controls (cleanliness, controlled areas, pest control).
- Equipment and utilities (calibration, maintenance, validation).
- Personnel hygiene and training (PPE use, SOP compliance, qualifications).
- Raw materials and supply chain (supplier approval, storage, segregation).
- Manufacturing processes (batch records, in-process controls, validation).
- Quality control and assurance systems (sampling, testing, deviation handling).
- Packaging and labeling (accuracy, integrity, tamper-proofing).
- Documentation and records (completeness, traceability, audit trails).
- Complaint handling, recalls, and CAPA programs.
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Step-by-Step GMP Audit Process in eAuditor
3.1 Pre-Audit Preparation
- Define the GMP audit checklist in eAuditor aligned with applicable regulatory guidelines.
- Review previous audit findings, CAPA reports, and production records.
- Notify relevant departments and assign audit responsibilities.
3.2 Facility and Environmental Controls
- Inspect cleanliness, layout, and segregation of controlled areas.
- Verify pest control measures and environmental monitoring results.
- Capture photos of non-compliant areas for documentation in eAuditor.
3.3 Equipment and Utilities
- Check calibration and maintenance records for critical equipment.
- Inspect validation reports for water systems, HVAC, and cleanrooms.
- Record deficiencies directly in eAuditor and assign corrective tasks.
3.4 Personnel Hygiene and Practices
- Observe adherence to hygiene protocols (handwashing, gowning procedures).
- Verify use of PPE and compliance with SOPs.
- Review training records stored digitally in eAuditor.
3.5 Raw Materials and Storage
- Check supplier approval processes and certificates of analysis (COAs).
- Inspect storage conditions, segregation of rejected/approved materials.
- Use barcode/QR code scanning within eAuditor to track inventory inspections.
3.6 Manufacturing Processes
- Review batch production records for accuracy and completeness.
- Inspect in-process control procedures for compliance.
- Validate adherence to SOPs and GMP-approved workflows.
3.7 Quality Control and Assurance
- Review laboratory practices, sampling protocols, and test records.
- Verify handling of deviations, out-of-specification results, and CAPA measures.
- Attach supporting lab documents to the eAuditor checklist.
3.8 Packaging and Labeling
- Inspect packaging lines for cross-contamination prevention.
- Verify label accuracy and tamper-proofing systems.
- Capture photo evidence of label compliance checks.
3.9 Documentation and Records
- Audit recordkeeping for completeness, accuracy, and traceability.
- Review electronic and paper-based logs for compliance with data integrity principles.
3.10 Complaints, Recalls, and CAPA
- Check systems for complaint handling and product recall procedures.
- Review effectiveness of corrective and preventive action programs.
- Assign responsibilities and deadlines for unresolved CAPA in eAuditor.
3.11 Post-Audit Reporting
- Generate an instant GMP audit report in eAuditor with all findings.
- Share reports automatically with QA managers, compliance officers, and executives.
- Highlight major risks, non-conformities, and recommended corrective actions.
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Post-Audit Analysis and Continuous Improvement
- Use eAuditor analytics to track recurring non-conformities across audit cycles.
- Monitor CAPA completion rates and effectiveness over time.
- Compare monthly/quarterly scores to assess improvement trends.
- Schedule refresher training and process revalidations for high-risk areas.
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Summary
Conducting a GMP (Good Manufacturing Practice) Audit using eAuditor provides a structured, evidence-based method to ensure compliance with Good Manufacturing Practices. By combining mobile inspections, real-time photo documentation, automatic scoring, action management, and reporting, eAuditor makes GMP auditing more efficient, transparent, and effective. This not only safeguards product quality and patient safety but also builds regulatory confidence and drives continuous operational improvement.