Ensuring proper temperature during storage and transport of pharmaceuticals and vaccines is crucial for logistics providers. Temperature mapping helps identify temperature variations within storage areas and means of transportation so that products remain safe and effective. In this article, we share seven essential tips for effective temperature mapping.

1. All rooms and objects should be checked for suitability

It is mandatory to have determined the suitability of spaces such as a warehouse or cold storage facility and transportation equipment such as a truck or cooler before they are used to store or transport drugs and vaccines. All rooms and objects used for storage or transportation must be checked for suitability. This is done through a qualification mapping, also called IQ mapping called.

2. Secure implementation and requirements in a Master Validation Plan.

The implementation and requirements of the mappings are secured in a Master Validation Plan. This way, all stakeholders know what the requirements and wishes are. This contributes to a first-time-right delivery of the mapping report. Clarity and transparency are the key to validating spaces, objects and transportation assets.

3. Make sure temperature standards and limits are known

Make sure the temperature standards and limits for all products you manage are known to your QA team. Different products have higher tolerances or resistance to temperature variations. This information can be helpful in optimizing storage conditions and determining the most appropriate approach for specific products.

4. Make sure your mapping protocol is clear and complete

A clear and complete mapping protocol is essential for performing consistent and reliable temperature mapping. Are there any ambiguities or uncertainties? Address these before performing the mapping.

5. Perform seasonal mappings

After performing the qualification mapping including the corresponding tests always follow the seasonal mappings (summer and winter studies). The completion of all mappings is important to ensure that storage and transportation conditions remain stable and meet the set standards under all weather conditions.

6. Re-mapping is necessary when changes are made or after five years

Re-mapping a space, object or means of transport is only necessary if changes have take placeoccurred that may affect the temperature course. If this is not the case, it is recommended to the mapping be repeated every 5 years.

7. Choose a partner with a proven track record

 

If you want to outsource the execution of the mapping, always choose a partner with a proven track record. That way you avoid surprises when the reports are delivered. A partner with a lot of experience can give you good advice, often even during the construction of a space or before the purchase of a means of transportation. The experience such a partner brings helps you make considered decisions and therefore save money.

The IGJ checks that you have followed the above points and that you can demonstrate this. Another important checkpoint is what you did with the information obtained during the mapping.

 

Would you like a free consultation from a mapping specialist? If so, please contact us.

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