When it comes to producing and storing temperature-sensitive products, sometimes the long list of terms and information involved in mapping can get a little confusing. Below is a list of abbreviations and key terms to help make digesting your mapping report and validation easier.
3PL: Third-Party Logistics- CAPA: Corrective and Preventive Action (Procedures)
- EDLM: Electronic Data Logging Monitor
- GMP: Good Manufacturing Practices
- IQ: Installation Qualification
- NIST: National Institute of Standards and Technology
- OQ: Operational Qualification
- PQ: Performance Qualification
- SLA: Service Level Agreement
- SOP: Standard Operating Procedure
Key Terms
Component: Any major piece, part, or assembly of the main equipment or subequipment that does not have its own power supply and could not operate as a standalone unit (valves, switches, etc.)
Controller: A device that interprets a mechanical, digital, or analog signal, generated by a sensor, to control equipment or components.
Deviation:
For IQ: Any discrepancy between the installation specifications and the actual (as found) installation.
For OQ: Any discrepancy between the protocol and the actual performed test, test function methodology, testing equipment, testing material, etc.
Electronic Data Logging Monitor: A small portable device that measures and stores environmental data (temperature, humidity, pressure, etc.) at predetermined time intervals using an electronic sensor.
IQ (Installation Qualification): The process of obtaining and documenting evidence that the premises, equipment, and supporting systems have been provided and installed in compliance with their design specifications.
Instrument: A device that interprets a mechanical, digital, or analog signal generated by a sensor and converts it into engineering units (°C, % RH, mA, etc.) through scaling.
Key Operating Parameters: Parameters that must be maintained to process or produce products with consistent quality attributes and those that may have an impact on the proper operation of the equipment.
OQ (Operation Qualification): The process of obtaining and documenting evidence, under controlled conditions, that the premises, equipment, and supporting systems operate following their design specifications.
PQ (Performance Qualification): The process of obtaining and documenting evidence that the premises, equipment and supporting systems, as connected, will consistently perform per the approved process method and specifications.
Refrigeration Equipment: The term ‘refrigeration’ or ‘refrigeration equipment’ means any equipment whose purpose is to lower air and product temperatures and/or to control relative humidity.
Sensor: A mechanical device (pressure switch, bimetal temperature switch, etc.), or a digital or analog transducer (limit switch, pressure sensor, temperature sensor, etc.) that generates a mechanical or electrical signal to an instrument or a controller to be interpreted.
Service Level Agreement: A service level agreement or contract is a negotiated agreement between the customer and service provider that defines the common understanding about materials or service quality specifications, responsibilities, guarantees, and communication mechanisms. It can either be legally binding or an informal agreement.
Standard Operating Procedure: A set of instructions having the force of a directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard operating policies and procedures can be effective catalysts to drive performance improvement and improve organizational results.
Temperature Controlled: Includes any environment in which the temperature is actively or passively controlled at a level different from that of the surrounding environment within precise predefined limits
Thermal Mapping: Documented measurement of the temperature or relative humidity distribution within a storage area, including identification of hot and cold spots.
Validation: Documented testing performed under highly controlled conditions, demonstrating that processes, methods, and systems consistently produce results meeting predetermined acceptance criteria.
