7 Components of a Cost-Saving CAPAs for Temperature Excursions
In case of a temperature excursion, GMP and GDP regulations require a Corrective Action & Preventive Action (CAPA). It is a structured process, which investigates and identifies root causes of problems and defines corrective action to prevent recurrences.
To create a useful CAPA, ask these questions:
• Who found the temperature excursion, when, and where?
• What is the scope of the case (shipment number, delivery, handling unit, pallet, product, batch)?
• What is the severity of the excursion?
a. What was the label/transport condition?
b. What was the highest (or lowest) temperature measure?
c. What was the number of excursion hours (can the product still be released based on stability budget)?
• What was the root cause of the excursion?
• What are corrective actions to eliminate this specific problem?
• Have similar cases happened before? Are there patterns in the data?
• Can we define preventative actions to make sure similar root causes are eliminated?
For a reliable CAPA process in cold chain management, a database is necessary where all data is available in a structured and well-documented way.