Monitoring for Regulatory Compliance & Product Safety
Temperature - Humidity - Moisture - Pressure - pH
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Case Studies

HPRA Licensed Wholesaler of Medicinal Products

The client company holds a wholesale licence from the HPRA. During a recent HPRA audit the rationale for the placement of the temperature monitoring sensors in the warehouse was audited. It was found that there was no documented rationale for the current locations of the continuous monitoring sensors which did not correspond to the recommendations of the last temperature mapping study /or the last temperature mapping study did not recommend locations for the continuous monitoring probes.

This was considered a major deficiency and as such the HPRA required that it be addressed as a matter of urgency. The audit report stated that this issue should be addressed within a specific time frame … months/days/weeks. The company were required to revert to the HPRA with their planned approach and timelines. The consequence of non-compliance would be a review or loss of the company’s Wholesale Distributors Licence .

The company’s RP contacted Rototherm to ask if we would work with them to resolve this issue.

Approach

In discussions with the customer Rototherm determined that the validation work required to conform with HPRA and EU GDP requirements was to perform seasonal temperature mapping studies of the warehouse. These studies would be performed using quality data loggers which would be regularly calibrated across temperature ranges consistent with the planned validation work and are regularly serviced to ensure consistent data quality.

Solution

Rototherm proposed the following:

  • Rototherm Validation Technicians perform a risk assessment and temperature monitoring audit of the warehouse
  • Rototherm Quality & Validation Department prepare the Protocol for the performance of the seasonal Temperature Mapping Studies.
  • Rototherm perform the seasonal Temperature Mapping Studies
  • Rototherm Quality & Validation Department prepare the Temperature Mapping Reports which would include documented recommendations on the placement of sensors for the continuous monitoring system
  • Rototherm review the reports with the client
  • Rototherm  work with the client to ensure that the continuous monitoring sensors were located correctly for all seasonal requirements.

Outcome

The client has fully documented, risk assessed, seasonal temperature mapping reports for their warehouse. The locations for the continuous monitoring sensors are clearly documented for warm and cold ambient conditions in these reports. These locations are also documented in their temperature monitoring SOP. The locations are audited regularly by their internal auditing procedures to ensure compliance. A follow up audit by the HPRA confirmed their confidence in the system and a continuance of the client’s licence

 

Logistics Company applying for an HPRA Licence

The client is a logistics company which  is in the process of preparing an application to the HPRA for a wholesale licence.  They have not yet addressed the temperature requirements for the application in compliance with HPRA and EU GDP guidelines.

The company’s RP designate  contacted Rototherm  to ask if we would work with them on this requirement

Approach

In discussions with the customer Rototherm determined that  to conform with HPRA and EU GDP requirements it was necessary was to perform seasonal temperature mapping studies of the facility.  These studies would be performed using quality data loggers which would be regularly calibrated across temperature range consistent with  the planned validation work and are regularly serviced to ensure consistent data quality. The results of the temperature mapping studies would determine the facility’s ability to maintain required storage temperatures.

The requirements for the continuous temperature monitoring system to comply with HPRA and EU GDP guidelines are that the sensors have an accuracy  of ±0.5⁰C, the sensors are calibrated at least annually, the system provides continuous live temperature data and has the ability to send alerts in the event that temperatures are recorded outside the set temperature limits.

Solution

Rototherm’s proposed  solution:

  • To perform seasonal Temperature Mapping Studies to determine the facility’s ability to maintain required storage temperatures and to determine the placement of the continuous monitoring sensors for warm and cold ambient conditions.
  • The IceSpy System 5 Temperature Monitoring and Alarming System was proposed for the continuous monitoring of the facility. This system is considered most suitable on the basis that it fulfils all of the requirements of the HPRA and EU GDP guidelines and is used in a large number of facilities which are regularly audited by the HPRA, MHRA, FDA etc.
  • Annual  SLA (Service Level Agreement ) to cover on-site calibration of the continuous temperature monitoring system to comply with HPRA and EU GDP guidelines and a Preventative Maintenance Check.

Outcome

The client has fully documented, risk assessed, seasonal temperature mapping reports for their warehouse. The locations for the continuous monitoring sensors are clearly documented for warm and cold ambient conditions in these reports.  These locations are also documented in their temperature monitoring SOP.

The IceSpy system calibrated and installed in locations recommended by the temperature mapping reports provides consistent temperature data and alarm alerts in compliance with HPRA and EUGDP guidelines.

The RP happily reported that the HPRA audit of the temperature mapping and monitoring of their facility was successful.  His words were  “you passed with flying colours”.