Introduction to Qualification, Validation and Mapping | Malaysia

There are many different regulations we could apply, but on one topic they are having the same concept. If you are working with pharmaceutical, food & beverage products and want to comply with GMP/GDP Guildlines, then you must qualified the facilities includes product, handle, store and transport.
 

What is Validation?

According to GMP/GDP Guildlines, a validation is to ensure the process or activity has the expected result and outcome. In Malaysia, National Pharmaceutical Regulatory Agency (NPRA) stated all quality relevant processes must be validated to ensure the maintenance of high standards quality and integrity of the distribution processes.
 
In validation, the first part of the validation is to define the expected results and the second part is to verify and document the process delivers the expected results. For an example, if you are storing pharmaceufical producs in a warehouse, you will need qualified staff to perform according to the SOP, you will also need specific equipment to ensure the goods is stored accordingly. In validation, all of the mentioned above should be considered in performing validation.


What is Qualification?

According to GMP/GDP Guildlines, a qualitication is the process to prove the facility, system, supplier & room fulfills the intended purpose. In a simple explaination, if the equipment is used in to produce, handle, store and transport pharmaceutical or food & beverage products, a qualification must demonstrate the equipment is fit to use.
 
For an example, if the fridge must maintain 2°C to 8°C, the qualification is to certified the fridge is consistently maintaining the temperature range 2°C to 8°C. As a result, the qualification always starts with the intended purpose and continues with an evaluation and documentation.


What is Temperature Mapping?
 
The temperature mapping study is the measurement and documentation of the temperature distribution within a specific area to find out the hottest and coldest spots. According to the World Health Organization (WHO) Guildlines, “Mapping may also be used to identify zones where remedial action needs to be taken”.
 
A temperature mapping study takes place for a time preiod, typically a few days or weeks, and monitors temperature and humidity in various locations inside the specific area including refrigerator, warehouse, box or container.

 
By The following step is to prepare a mapping plan, the calibrated data loggers are clearly labeled, configured, and placed at the defined mapping points. After the defined time period, all the data loggers are collected and analyse the hottest and coldest spots in the room. The hottest and coldest spots are recommended to install Temperature & Humidity Sensors, since a temperature excursion at those spots would be most critical first and therefore measure first.


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