The Eupry Glossary

The GxP fundamentals

• GxP: A set of quality guidelines and regulations covering Good practices (like manufacturing, distribution, and lab work) in life sciences. These rules help ensure that products are safe, consistent, and traceable. GxP is an umbrella term for more specific practices like GMP and GDP. Learn more about GxP compliance.

• GMP: Stands for Good manufacturing practice. It ensures products are consistently produced and controlled according to quality standards. GMP covers manufacturing processes, equipment, and documentation.

• GDP: Good distribution practice. Ensures that pharmaceutical products are stored and transported under appropriate conditions to maintain quality and integrity throughout the supply chain.

• GLP: Good laboratory practice. Ensures the consistency, reliability, and integrity of non-clinical lab studies – often in R&D or product safety testing.

• ALCOA plus: A framework for data integrity. It stands for Attributable, Legible, Contemporaneous, Original, and Accurate – with added expectations like Complete, Consistent, Enduring, and Available. Ensures trustworthy data during audits and regulatory reviews.

Regulatory frameworks

• Annex 15: A part of EU GMP guidance outlining expectations for qualification and validation. It defines principles for equipment, systems, and processes to be fit for purpose.

• ICH Q9: A global guideline on quality risk management. Encourages risk-based approaches to decision-making in pharma processes and validation.

• FDA: The US Food and Drug Administration. Sets regulations and enforces compliance for drugs, devices, and food in the United States.

• FDA 21 CFR Part 11: A regulation from the U.S. FDA defining criteria under which electronic records and signatures are considered trustworthy and equivalent to paper records. Ensures digital records and e-signatures in your temperature compliance system are reliable and audit-ready. Read more about Part 11 compliance.

• EMA: European Medicines Agency. Oversees evaluation and supervision of medicines in the EU, including GMP/GDP compliance.

• MHRA: UK's Medicines and Healthcare products Regulatory Agency. Ensures that medicines and medical devices meet applicable standards.

• ISO 17025: International standard for testing and calibration labs. Confirms lab competence, technical validity, and traceability. Learn more about ISO 17025 calibration.

Validation

• DQ: Design qualification. Verifies that equipment or systems are designed correctly and meet intended use before installation.

• IQ: Installation qualification. Confirms that equipment has been installed correctly according to manufacturer specs and site requirements.

• OQ: Operational qualification. Ensures the system or equipment performs as expected under defined conditions.

• PQ: Performance qualification. Confirms the system consistently performs as intended under real-world conditions.

• CQV: Commissioning, qualification, and validation. A complete validation lifecycle approach that integrates equipment commissioning with qualification activities.

• VMP: Validation master plan. A high-level plan that outlines validation strategy, responsibilities, and timelines across systems or facilities.

• Acceptance criteria: Predefined limits that determine if a test or validation passes or fails. Critical for audit transparency.

• Validation fatigue: A common issue when over-validation leads to wasted time and resources. Often caused by unclear risk prioritization.

• System validation: The documented process of proving that a software or monitoring system performs as intended, reliably, reproducibly, and compliantly. It is required for all GxP-related digital tools to ensure compliance and audit readiness.

Learn more in our thermal validation guide.

Temperature mapping

• Risk-based mapping: A validation method where mapping efforts focus on higher-risk areas or units. Saves time while meeting compliance. Learn more in our risk-based mapping guide.

• Mapping protocol: The plan that outlines how a temperature mapping study is performed, including sensor placement, duration, and acceptance criteria. See our mapping protocol template.

• Sensor placement: Strategic positioning of loggers in high-risk or extreme zones (like hot/cold spots) to ensure accurate mapping data. See our guide on sensor placement best practices.

• Hot and cold spots: The highest and lowest temperature zones within a unit or space. These are critical to identify during mapping.

• Non-conformities: Events or results that fall outside defined acceptance criteria during validation or mapping. Must be documented and resolved.

• Continuous mapping: An approach that keeps collecting mapping-level data over time using many loggers. Helps avoid periodic re-mapping and ensures ongoing compliance. Learn more about continuous temperature mapping and our solution.

• Freezer mapping: Techniques and best practices for validating ultra-low temperature units. Explore our freezer mapping guide.

• Mapping data logger calculator: Use our calculator tool to estimate logger requirements for your mapping study.

• Reefer temperature mapping: The process of of verifying that a refrigerated shipping container (a reefer) consitently maintains required pharmaceutical storage temperatures. Learn more about GDP-compliant reefer temperature mapping for pharmaceuticals.

Monitoring

• Real-time monitoring: Continuous tracking of temperature or humidity using connected sensors. Enables immediate alerts and audit readiness. Learn more about temperature monitoring.

• Alert thresholds: The limits (e.g., max/min temperature) that trigger alarms when exceeded. Crucial for product safety and compliance.

• Deviation handling: A structured way to respond when conditions fall outside thresholds. Includes documenting, investigating, and resolving the issue.

• Data integrity: The assurance that monitoring data is complete, accurate, and unchanged. Key for audits and regulatory acceptance.

• Monitoring system: A digital setup that collects, stores, and displays temperature (and sometimes humidity) data from sensors in real time. It's the backbone of compliance visibility and proactive alerting. Systems must meet GxP and audit standards. Learn more about monitoring systems.

Calibration

• Calibration certificate: Official proof that a device (like a logger) has been tested and meets accuracy standards.

• Traceability: The ability to trace a calibration result back to a national or international standard. Confirms the reliability of measurements.

• Calibration interval: The time between required calibrations. Too long – risk of drift; too short – wasted resources.

Learn more about automated calibration.

Devices

• Data logger: A sensor device that records environmental data like temperature over time. Used in monitoring and mapping.

• Wireless data logger: A logger that transmits data via Wi-Fi or radio, often in real time. Reduces manual work and supports automation. Learn more about wireless loggers.

• Thermocouple: A sensor made of two metals that generates a voltage proportional to temperature. Common in high-accuracy validations.

• Transmitter: Sends sensor data to a central system. Key in real-time monitoring setups.

• Logger fittings: Accessories (e.g., clamps, holders) used to secure loggers during mapping to ensure stable readings.

Digitalization and automation

• Digital validation: Using digital tools and software to plan, execute, and document validation activities. Speeds up audits and standardizes processes.

• Automated calibration: A process that uses technology to handle calibrations without manual steps – often faster, with fewer errors.

• Digital reporting: Auto-generated compliance reports you can export and present during audits. Cuts down audit prep time.

• Central dashboard: A single interface showing data across sites and devices. Useful for quality teams managing multiple units or locations.

• Unified temperature compliance: A streamlined approach that combines monitoring, mapping, and calibration in one process to reduce error and inefficiency. Learn why and how to unify your compliance.

Quality management

• SOP: Standard operating procedure. A written instruction detailing how to perform a task. Ensures consistency and compliance.

• GDocP: Good documentation practices. Guidelines on how to write, update, and store records to meet regulatory expectations.

• Internal audit: A self-check of systems and processes. Used to catch issues before external inspections.

• KPI: Key performance indicator. A measurable value that shows how well a process or system is performing (e.g., alert resolution time).

• Quality deviation: A documented departure from expected process or outcomes. Triggers investigations and sometimes CAPAs.

Steam-in-place (SIP)

• F zero value: A calculated value that measures sterilization efficacy over time. Central to validating steam sterilization.

• Dryness fraction: Indicates how much of the steam is usable (dry) vs. water. Impacts sterilization efficiency.

• Steam trap: A device that removes water from steam lines. Ensures consistent temperature and sterilization quality.

• Non-condensable gases: Air or gases in steam that reduce sterilization performance. Must be monitored and controlled.

• Steam quality: A measure of how effectively steam can transfer heat. High-quality steam improves sterilization outcomes.

Learn more in our SIP validation guide.

Audit and inspection readiness

• Audit trail: A secure, chronological record of actions in a system. Critical for data integrity and traceability.

• CAPA: Corrective and preventive action. Steps taken to fix and prevent quality or compliance issues.

• Deviation report: A document that records any non-conformance, including what happened and how it was handled.

• ALCOA plus: Expanded data integrity principles – crucial for audit acceptance.

• Data access control: System permissions that restrict data access based on roles. Helps prevent unauthorized changes.

Cold chain and logistics

• Cold chain: The end-to-end temperature-controlled supply chain. Ensures product safety from manufacturing to delivery.

• Controlled temperature unit: Any storage or transport unit (like a fridge or truck) designed to maintain specific temperature ranges.

• Ambient monitoring: Observing temperature and humidity in spaces not actively cooled (like warehouses). Still important for product safety.

• Shipping validation: Testing and documenting that a shipment can maintain required conditions. Often needed for regulatory approval.

• CEIV Pharma: A certification that confirms an organization meets GDP requirements for air cargo pharma transport. Learn more about CEIV Pharma certification.

• GDP compliance: Meeting the standards of Good distribution practice – especially critical in pharma logistics.

Pharmaceutical operations

• Pharma-ready: A term used to describe operations, systems, or facilities that meet the specific regulatory and quality expectations of the pharmaceutical industry. Often implies GxP alignment, audit-readiness, and validated equipment.

• Product supply: The logistics and quality-controlled delivery of pharmaceutical goods. Encompasses everything from manufacturing release to storage and distribution.

• Pharma client expectations: The compliance, validation, and data transparency standards expected by pharmaceutical customers. Critical for logistics and service providers aiming to work with pharma.

• Clinical trial supply chain: The controlled, often global distribution of investigational medicinal products (IMPs) used in clinical studies. Requires rigorous temperature monitoring and traceability.

• Regulatory inspections: On-site evaluations by authorities (e.g., FDA, EMA) to assess compliance with pharmaceutical regulations. Passing is essential to maintain licenses and market access.

• Pharmaceutical quality systems: The set of policies, SOPs, validations, and controls designed to ensure consistent product quality in pharma manufacturing and distribution.