Regulators are requesting documented evidence that temperature sensitive products are being shipped within the temperature range specified on the label.
This is applicable to cold chain products (+02+08°C) and ambient products or CRT Products (+15+25°C or stored below +30°C)
Temperature excursions can affect product’s efficacy, leading companies to incur in major costs if quarantine and product recalls have to be performed. Representing an ongoing risk to patient safety. More legal cases are appearing where proof of delivery in temperature is being used as a mechanism to secure compensation claims.
A cold chain audit from an operational perspective will identify gaps, non-conformances and potential high risks. Our in depth review of the operational process within a company inevitably highlights major issues which are often not identified by normal internal audits
We provide an assessment on your current operations via a GDP – GAP Analysis Audit, followed by a full audit report and recommendations.
Our consultants perform audits on site, together with the responsible person (RP) and process owners, making sure the results are accurate and reliable to increase your business efficiency.
All our audits are conducted following EU Good Distribution Practices (GDP) Guidelines and local regulations depending on the country/countries where your products are shipped.
Customer Quote: “80-90% of our temperature excursions were a result of incorrect processes and were caused before the products were dispatched from site”
The GDP Gap Audits are conducting from two project aspects:
