Calibration in GxP Applications - Introduction

Pourquoi l'étalonnage est-il nécessaire pour les applications BPx ?

L'étalonnage est essentiel dans les environnements réglementés par les BPx (Bonnes Pratiques de Fabrication (BPF), Bonnes Pratiques de Laboratoire (BPL), Bonnes Pratiques de Distribution (BPD), etc.) pour garantir l'exactitude des données, la conformité et la qualité des produits.

• Les réglementations GxP (FDA, EMA, OMS, etc.) exigent un étalonnage pour maintenir la fiabilité des mesures.
• La norme FDA 21 CFR Part 11 et l'annexe 11 de l'UE exigent la traçabilité des enregistrements électroniques, y compris la précision des capteurs. Contactez-nous pour obtenir gratuitement le livre blanc RMS
• Le non-respect de ces exigences peut entraîner des avertissements réglementaires, des rappels de produits ou des conséquences juridiques.

• De nombreux produits pharmaceutiques et biotechnologiques (par exemple, les vaccins, les produits biologiques, les principes actifs) nécessitent un contrôle environnemental strict.
• Les écarts de température lors du stockage peuvent entraîner la dégradation du produit, réduisant ainsi son efficacité et sa sécurité. Exemple : si un vaccin est stocké à 10 °C au lieu de la température requise de 2 à 8 °C, il peut devenir inefficace.

• Un étalonnage précis garantit la fiabilité des données enregistrées pour la libération des lots et les études de stabilité.
• Les pistes d'audit et la traçabilité sont essentielles pour prouver la conformité lors des inspections. En savoir plus sur les données de piste d'audit
• Sans étalonnage, la dérive du capteur peut entraîner des enregistrements de surveillance environnementale inexacts, rendant invalides les données de libération des lots.

• L'étalonnage basé sur les risques empêche les écarts d'affecter la sécurité des produits et la conformité réglementaire.
• Identifying drift early avoids potential financial losses from rejected batches or recalls.
• Assure la validation continue des processus dans les environnements GxP.

• L'étalonnage de routine améliore l'efficacité du processus en minimisant les écarts liés aux capteurs.
• Le suivi automatisé de l'étalonnage permet d'optimiser les calendriers d'étalonnage en fonction des performances réelles des capteurs..
• Predictive maintenance can be implemented by analyzing drift trends and reducing downtime.

What are the Best Practices?

The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides comprehensive guidance on establishing a calibration management system that aligns with GxP regulatory expectations. The guide emphasizes a structured, risk-based approach to ensure the accuracy and reliability of instruments critical to product quality and patient safety.

• Instrument Risk Assessment: Classify instruments based on their impact on product quality and patient safety. This assessment helps prioritize calibration efforts, focusing resources on instruments with the highest risk.

• Calibration Program Management: Develop a structured calibration program that includes:

• Defined calibration procedures
• Scheduled calibration intervals
• Criteria for acceptance
• Processes for handling out-of-tolerance conditions.

• Documentation: Maintain comprehensive records of all calibration activities to ensure traceability and compliance. Documentation should include:

• Instrument identification
• Calibration dates
• Results
• Personnel involved. Learn more about Calibration in RMS

• Corrective Actions:
Implement procedures to address instruments that fail calibration or are found out of tolerance. This includes assessing the impact ocalibn product quality and taking necessary actions to mitigate any risks.

• Continuous Improvement: Regularly review and update the calibration management system to incorporate new technologies, regulatory changes, and industry best practices.

By following these recommendations, organizations can ensure their calibration processes are efficient, compliant, and aligned with current industry standards.

The Example of Probe Calibration in Refrigerators

The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) recommends a risk-based approach for calibrating probes in refrigerators used in GxP environments (e.g., pharmaceutical, biotech, and healthcare industries). The key recommendations include:

• Risk-based scheduling: The frequency should be based on the impact of a temperature deviation on product quality.

• Typical intervals:
• Annually: Standard recommendation for stable environments
• Semi-annually or quarterly: If the fridge stores high-risk products (e.g., vaccines, biologics)
• Real-time monitoring with drift analysis: Some organizations perform continuous monitoring and adjust calibration schedules based on observed drift

• Comparison against a reference standard:

• Use a traceable, high-accuracy reference thermometer (calibrated to ISO 17025 standards).
• The reference should have a better accuracy than that of the unit (device/probe) to be calibrated.
• Place both the probe and reference sensor in a temperature-stable medium (e.g., glycol buffer or air).
• Measure at least two points within the operating range (for example 2°C and 8°C for a medical fridge that are values close to the operating setpoints of the fridge).

• On-site vs laboratory calibration:

• On-site calibration is preferred to minimize sensor removal effects.
• If using a calibration lab, ensure traceability and requalification upon reinstallation. PST has a range of ISO-17025 calibration laboratories around the world to carry out accredited calibrations.

• Define tolerance limits based on regulatory requirements and product stability needs. The typical tolerance for many applications is ±0.5°C; however, this may vary depending on the specific application.
• If out of tolerance, perform an impact assessment to determine if stored products are compromised.

• Maintain detailed calibration records (date, reference standard used, results, technician). See an RMS Calibration Protocol Sample
• If using automated monitoring systems, ensure data integrity and audit trail compliance.

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