Perform GMP Inspection using eAuditor
A (Good Manufacturing Practice) GMP Inspection is a formal review process conducted to ensure that a manufacturing facility complies with established standards and regulations designed to guarantee the safety, quality, and consistency of products, particularly in industries like pharmaceuticals, food, cosmetics, and medical devices.
Performing a GMP (Good Manufacturing Practice) Inspection using eAuditor ensures a thorough and standardized assessment of compliance with regulatory manufacturing standards. eAuditor provides a digital platform to document findings in real-time, streamline inspections, assign corrective actions, and maintain a consistent audit trail, supporting both internal quality systems and external regulatory readiness.
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Purpose of GMP Inspection in eAuditor
The goal of conducting GMP inspections with eAuditor is to:
- Ensure manufacturing processes meet industry and regulatory standards
- Verify cleanliness, equipment calibration, and controlled environments
- Confirm adherence to SOPs (Standard Operating Procedures)
- Evaluate quality assurance and quality control mechanisms
- Identify deviations or non-conformities for timely correction
- Maintain detailed, accessible records for audits or compliance reviews
- Reduce the risk of product recalls, contamination, or safety breaches
A digital tool like eAuditor enhances the accuracy and repeatability of inspections.
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Preparing for GMP Inspection Using eAuditor
Preparation is essential and includes:
- Developing or selecting GMP-specific checklists tailored to your industry
- Reviewing previous inspection reports, CAPAs (Corrective and Preventive Actions), and audit findings
- Scheduling inspections across various departments such as production, packaging, storage, and QA/QC
- Ensuring all inspectors are trained on GMP principles and eAuditor usage
- Gathering documentation such as SOPs, equipment logs, and training records
- Defining the scope: routine inspection, pre-audit check, or supplier evaluation
Thorough preparation ensures complete coverage and efficient execution.
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Step-by-Step GMP Inspection Process Using eAuditor
3.1 Facility Hygiene and Sanitation
- Inspectthe cleanliness of production areas, storage zones, and corridors
- Verify regular sanitation schedules and proper cleaning documentation
- Check for pest control implementation and waste disposal practices
- Confirm proper use of cleanroom protocols (if applicable)
Cleanliness directly impacts product safety and quality.
3.2 Personnel Hygiene and Training
- Verify use of appropriate protective clothing, gloves, and hygiene practices
- Check staff entry protocols into controlled areas
- Review training records for GMP awareness and role-specific SOPs
- Assess compliance with handwashing and illness reporting procedures
Trained and compliant staff are essential to maintaining GMP standards.
3.3 Equipment and Calibration
- Ensure equipment is clean, maintained, and functioning correctly
- Check calibration logs and certificates for accuracy
- Confirm that maintenance schedules are followed and documented
- Evaluate use of validated software or automated systems
Reliable equipment prevents production errors and deviations.
3.4 Documentation and Record-Keeping
- Review batch records, production logs, and deviation reports
- Confirm real-time documentation of manufacturing processes
- Assess control of electronic and hard-copy records
- Verify document version control and access restrictions
Accurate records support traceability and regulatory compliance.
3.5 Material Handling and Storage
- Inspect the conditions of raw material and finished goods storage
- Check FIFO (First In, First Out) practices and expiration date monitoring
- Verify labelling, segregation of rejected materials, and quarantine procedures
- Assess supplier traceability and material specifications
Proper storage prevents contamination and ensures material integrity.
3.6 Production Process Controls
- Observe process adherence to SOPs and quality specifications
- Assess in-process quality checks and sampling procedures
- Confirm documentation of deviations or out-of-spec results
- Review critical control points and automation validation (if used)
Control over production steps ensures product consistency and safety.
3.7 Quality Control and Final Product Testing
- Evaluate QC lab operations, test result documentation, and equipment calibration
- Confirm retention sample storage and traceability
- Review non-conforming product handling and retesting protocols
- Verify compliance with release criteria and sign-off authority
Strong QC safeguards product quality and regulatory conformance.
3.8 Environmental Controls
- Check temperature and humidity monitoring systems in sensitive areas
- Assess cleanroom classification, air handling units, and HEPA filter maintenance
- Confirm that logbooks for environmental parameters are accurate and accessible
- Observe cleaning practices for floors, walls, and ceilings
Environmental integrity supports contamination control.
3.9 Final Review and Reporting
- Summarize inspection results with photos, evidence, and non-compliance areas
- Assign corrective actions with deadlines and responsible parties
- Collect digital signatures from inspectors and supervisors
- Generate automated reports for regulatory and internal audits
- Share reports with QA and compliance teams
Transparent reporting helps close gaps and drive continuous improvement.
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Post-Inspection Management with eAuditor
After the inspection, eAuditor enables:
- Real-time corrective action tracking
- Audit trail preservation for regulators
- Trend analysis on recurring issues or root causes
- Task delegation and automated follow-up alerts
- Historical data access for internal reviews or certifications
These features make compliance more sustainable and proactive.
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Customization and Integration Features in eAuditor
To tailor GMP inspections:
- Modify checklists based on your facility’s processes and risk points
- Use conditional logic for targeted inspections (e.g., sterile areas vs. non-sterile)
- Include rich media like photos, diagrams, and notes for better context
- Set recurring schedules for routine GMP audits
- Integrate with CAPA systems, ERP tools, and document control platforms
- Add multilingual support for global teams
Custom tools make inspections more relevant, reliable, and scalable.
Summary
Performing a GMP Inspection using eAuditor empowers manufacturers to enforce high standards of cleanliness, process control, documentation, and safety. The digital platform improves inspection consistency, speeds up corrective actions, and supports audit readiness. By aligning with regulatory expectations and internal QA standards, eAuditor helps ensure safe, high-quality product manufacturing in a controlled and transparent environment. https://eauditor.app/2025/06/11/gmp-inspection-checklist/
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