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Regulations Drive Temperature Monitoring Practices

10.Oct.2014

On 30th September, ELPRO Services hosted a workshop on

«Making Your Temperature Data Work for You»

at the IQPC Boston event. The 3 hour workshop attended by 55 industry professionals was focused on trending temperature data to evaluate cost-saving logistics process improvements whilst at the same time using the data to meet regulatory expectations for CAPAs, stability data use and sufficient cold chain control of medicinal products.

A highlight of the workshop was Mary Foster’s presentation from the United States Pharmacopeia on «GDP USP & Regulatory Agency Requirements for Temperature Data». Mary outlined the USP «new 1083» standards document that specifically pertains to Quality Management and Environmental Monitoring; and provided feedback from the recent EU GDPs and brand new FDA inspector’s comments she collected in the weeks prior to the workshop.

Here are some of the highlights of the industry standards and regulatory guidelines that pertain to temperature data management.

Performance Qualification (PQ) – «USP 1083» is relevant to all owners of cold chain equipment, facilities, utilities, shipping containers, and dedicated temp controlled vehicles. A periodic check should be conducted using a calibrated monitoring system. For in-transit, a retrospective review with cargo monitoring & risk understanding should be documented and justified as well. USP 1083 outlines that written SOPs should include the following elements for all storage facilities & dedicated vehicles when monitoring environmental conditions:

  • operation of the device
  • frequency of calibration
  • monitoring interval
  • data recording
  • data interpretation (including alarms)
  • responsible person contact information
  • in addition: all monitoring devices should be calibrated according to their intended use/at least annually

Mary also relayed that this part of «1083» on environmental monitoring is reflective of the European GDPs, Chapter 3.2 on Qualification & Validation that describes facility owners should periodically map their warehouses, refrigerators and freezers to ensure there are no extreme fluctuations and all parts of the facility are evenly controlled temperatures.

Transportation mapping and qualification - also falls under Performance Qualification (PQ) regulations. Specifically EU GDP Chapter 9.2 outlines thorough risk assessment of delivery routes should be conducted to determine where temperature controls are required. Temperature monitoring equipment during transport within vehicles and/or containers should be maintained & calibrated at regular intervals/at least once a year.

Excursion Reporting – under USP 1083.1 sub chapter on Quality Management it outlines both systemic and individual excursions must be documented. Systemic problems within the cold chain should be documented in written deviation reports and a root cause analysis conducted including trending of the data, impact to quality and formalizing a corrective action/preventive action (CAPA) so future occurrences are limited. Any non-conformance or single deviations should be documented also, considering all of the following:

  • assessment of the excursion
  • stability
  • shipping studies
  • MKT data
  • temp excursion studies
  • temp cycling studies

Inspector’s Expectations - Mary interviewed three FDA inspectors to understand what they look for in temperature data. The message was clear – Although temperature control may not be the first question they enquire about but if they see a potential issue, FDA will dig until it clears up or they see a problem. They may start with investigating storage conditions but can quickly lead to the distribution process being reviewed as well. Specific comments from FDA investigators:

  • «When I inspect I would look at transportation processes if there were temperature deviations that led me in that direction.»
  • «I know temperature and how the data is documented and how it is retrievable is something that I could review, but I don’t routinely ask for that data. This is an area that can be a rabbit hole if the data is not available but I have not spent much time looking for it unless there is a problem. Then I going down that rabbit hole.»
  • «I look at in the warehouse for storage controls on temperature. Would ask questions if something seemed wrong»

The «Making Your Temperature Data Work for You» workshop was part of the IQPC Cold Chain Global Forum, attended by 700 temperature control quality and logistics industry pharmaceutical professionals. During the exhibition including 78 different exhibitors, ELPRO had a lot of discussions around Libero C PDF Loggers used for distribution in both clinical and commercial supply chains. Libero C’s are ideal for cold chain distribution because of their ease-of-use by third parties at both sending sites and receiving sites. Because there is no hardware or software required to use the devices, receiving sites can easily download the device and email it to central QA. QA appreciates the Liberos create a unique 1 page PDF that has the raw data embedded, ready for future data analysis and long-term document compliance.

It was a busy two days in Boston and we appreciated meeting potential customers and discussing individual requirements. We are looking forward to the next exhibition. ELPRO plans to run another educational workshop at the IQPC Boston 2015 event.

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