Temperature mapping data is invaluable when it comes to storing your temperature sensitive products. Through the process of mapping, you are able to collect continuous data at a number of set points throughout a facility. By analyzing this data, you can locate the hot or cold spots that exist throughout any given structure. However, at times, the mapping data can be a little overwhelming, especially when accompanied by a validation. What does that mean? Where did that come from? What do I need to know? What is that? Thanks to The World Health Organization’s Model Guidance for the Storage and Transport of Time and Temperature–Sensitive Pharmaceutical Products, we have listed out the key terms and abbreviations 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- Operation Qualification
PQ- Performance Qualification
SLA- Service Level Agreement
SOP- Standard Operating Procedure
Component: Any major piece, part or assembly of the main equipment or sub-equipment 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 an equipment or component.
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.
Installation Qualification IQ: 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 in order to process or produce products with consistent quality attributes and those that may have an impact on the proper operation of the equipment.
Operational Qualification OQ: The process of obtaining and documenting evidence, under controlled conditions, that the premises, equipment and supporting systems operate in accordance with their design specifications.
Performance Qualification PQ: The process of obtaining and documenting evidence that the premises, equipment and supporting systems, as connected together, will consistently perform in accordance with the approved process method and specifications.
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 in order 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 pre-defined limits
Validation: Documented testing performed under highly controlled conditions, demonstrating that processes, methods, and systems consistently produce results meeting pre-determined acceptance criteria.
We understand that it can be overwhelming to look at mapping data. Luckily, we're here to help you digest, analyze, and understand your report.