Typically we find our selves working  with customers who are in the following situation:

Existing HPRA Licence

Company has an HPRA licence and a recent HPRA audit has shown a major deficiency in compliance with the placement of continuous monitoring probes. The audit report identifies the need for a temperature mapping study to be carried out both winter and summer. It also identifies the requirement that the continuous monitoring system be deployed in accordance with the findings of the temperature mapping study.  Non compliance with these requirements poses a major risk to the business. The consequence of non compliance can be as extreme as the loss of the company’s licence to store pharmaceutical product.

New Applicaion for HPRA Licence

Company 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 GDP guidelines.

They  need to

• Assess the ability of their facility to maintain the required product storage temperature range
• Identify a temperature monitoring system to comply with the HPRA guidelines.
• Establish  an effective system of temperature monitoring

How we help

Rototherm can assist by performing a risk assessment and temperature monitoring audit of the facility. Using the information gathered during this audit we submit a project proposal. A typical project would include the following: 

When the required elements of the proposal are agreed a project plan is drawn up with timelines and responsibilities specified.

After the completion of the Validation Process it is crucial to maintain the integrity of the system by Annual Calibration and Preventative Maintenance