1. Maintenance Program
A structured preventive and corrective maintenance program ensures that equipment remains in good working condition.
- Planned Preventive Maintenance (PPM): A schedule is established for routine inspections and servicing based on manufacturer recommendations, usage history, and criticality of equipment. This helps prevent unexpected failures and process deviations.
- Corrective Maintenance: When breakdowns or deviations occur, prompt and documented corrective action is taken. Equipment is clearly labeled as “Out of Service” until maintenance is completed and it is requalified if necessary.
- Maintenance Documentation: All maintenance activities are logged, including date, technician name, description of work, parts replaced, and impact assessment on ongoing or completed batches.
- GMP Controls: Maintenance personnel must follow GMP practices, including gowning, cleaning, and documentation. They may require supervision if entering clean areas.
2. Calibration Program
Calibration ensures that instruments and equipment provide accurate, reliable measurements within defined limits.
- Calibration Schedules: Each instrument has a defined calibration frequency based on risk and manufacturer guidance. The schedule must be adhered to,GMP Certification services in Kuwait with extensions only permitted under a documented risk assessment.
- Traceable Standards: Calibration must be performed using certified reference standards traceable to national or international standards (e.g., NIST).
- Calibration Records: These must include the date of calibration, standard used, pre- and post-calibration results, technician identity, and next due date. Results outside of tolerance trigger an investigation and may require batch impact assessment.
- Labeling: Calibrated equipment is labeled with the calibration status, including the last calibration date and next due date. This helps ensure only in-calibration equipment is used.
3. Change Control and Impact Assessment
- Post-Maintenance Verification: After major maintenance or calibration affecting critical parameters, GMP Certification process in Kuwait equipment may require requalification or performance checks before returning to production use.
- Change Control: Any changes to equipment (e.g., part replacement, software updates) must go through formal change control, including risk assessment and regulatory impact analysis.
4. Training and SOPs
- Trained Personnel: Only trained and qualified personnel should perform maintenance and calibration. Training records must be maintained and verified regularly.
- Standard Operating Procedures: All maintenance and calibration activities must be performed following detailed SOPs that describe the method, tools, safety precautions, documentation, and quality checks.
5. Audits and Continuous Improvement
- Internal Audits: Regular audits assess compliance with maintenance and calibration procedures.
- Deviation Management: Any discrepancies or failures are documented, investigated, and corrective actions implemented.
Conclusion
GMP Implementation in Kuwait in equipment maintenance and calibration is ensured through planned schedules, traceable standards, thorough documentation, trained personnel, and quality oversight. These controls help maintain equipment performance, ensure accurate measurements, and copyright product quality and regulatory integrity.