Temperature monitoring is essential for your product, not only in the manufacturing stage, but also at all stages of storage and transport. Even more so, in case of pharmaceutical and medical products.
Over time, agencies like the FDA and ICH have taken measures like making data logging mandatory. Even if the products are exposed to higher temperatures / moisture levels for more than a few minutes, the rules dictate the entire lot must be discarded. But how do the Pharmaceutical companies ensure that the goods actually stay within the specified temperature at all times? What documented proof exists that the goods were indeed maintained within the specified temperature range right from manufacture to storage?
Here are 3 top reasons why it is good practice (even mandatory in some cases), to constantly monitor your products:
1) Regulations and Guidelines
The EU GDP guidelines (document 94/C63/03) explain that drugs are expected to be held at the right condition at all times throughout storage and transport. It also establishes that a quality system is to be in place to ensure that the distributor, as well as the manufacturer, is responsible for this activity. Further more, 21 CFR guidelines make it compulsory for all Pharma companies to maintain a tamper-proof log of temperature and humidity data for audit purposes.
FMCG and Pharma companies are frequently sued due to the perishable and sensitive nature of their goods. Hard coded evidence of temperature and real time handling data can be a saviour in such cases. Monitoring devices provide irrefutable evidence about whether the products were stored properly at each and every stage of its lifetime. On the other hand, absence of this information might just incriminate the company!
3) It’s too Risky!
Not having a device constantly track the health of your products during production and transport can prove to be very risky. Just a few of the risks are:
- Risk of losing credibility with investigators, auditors and distributors.
- Risk of losing the entire batch if not monitored constantly during manufacture/storage.
- Risk of losing out on insurance claims due to insufficient data.
Overall, you’ll just be a lot safer and smarter knowing the condition of your products right from the time it leaves your factory and reaches your customers’ hands.
From a business standpoint the benefit of using a temperature monitor is the assurance that it delivers information otherwise not available. Ultimately, the temperature monitor delivers proof of compliance and enables the evaluation of continuous process improvement. This means that companies engaged in manufacturing and transporting temperature sensitive products must have a monitoring system in place, which not only logs temperature values in real time, but also alerts the right person when the temperature values exceed thresholds.
Products like the Blake (Temperature and Humidity Monitor) let you log temperature values, download detailed reports with a single click, set thresholds, and also give you real time alerts over SMS/Email in case the temperature rises above the threshold. Powered by Bolt WiFi Module, and equipped with industrial grade sensors, Blake is live and kicking in Pharma production facilities and cold storages across India.