How EU directives on GDP affect the cold chain of pharmaceuticals
How EU directives on GDP affect the cold chain of pharmaceuticals:
The European Directives On good manufacturing and distribution practices aim to propose a framework of regulations to ensure the safety and quality of medicinal products and, end, The safety of the consumer and the patient.
The basis of EU GDP directives is that storage spaces and facilities should be checked. This includes:
- The temperature,
- The humidity,
- Lighting,
- Cleanliness, etc..
It is imperative, The control of the most aspects possible, which can affect the safety and quality of a medicinal product.
The professional services team of Sensitech Life Sciences It works with customers to identify challenges and focuses mainly on two key factors that affect safety and quality: temperature and humidity. Depending on the local climate and the stored product, The focus can only be on temperature and/or temperature and humidity. In Europe, Main focus is on temperature. We help our customers implement the guidelines by running multiple projects. One example of such a project is the temperature mapping, Something specifically highlighted in EU directives:
When to map the installation
- The temperature mapping, It should be carried out in the storage area before use and under representative conditions …
- Mapping should be repeated in accordance with the results of the risk assessment
- Or when significant modifications to the temperature control facility or equipment are made … EU GDP/GMP; Commission Guideline 2013/C 343/01, Chapter 3.2.1)
At Sensitech®, We advise our customers to perform at least three temperature mapping: One before using the storage space (Blank mapping) and two seasonal (Summer and winter) Matches once the installation is used to identify any problems with temperature management in the most extreme weather conditions. Our group defines the “Store” As “Each area of an installation where temperature sensitive product is kept for prolonged periods of time”. The group focuses not only on the specified storage space, But in quarantine, The quality, The incoming / Outbound and any other site that will be found the product. Each of these sites will be mapped. Combined with information from the site visit and additional temperature information from heating systems, Ventilation and Air conditioning (Hvac) and external temperatures, A thermal mapping results in a clear overview of the performance of the installations in terms of temperature management.
Conclusion
It is important to keep in mind that every time changes occur in the installation, Whether it is:
- Change HVAC settings
- Extension (or decrease) A storage area size
- or adjusting to product storage heights etc.,
In these cases the mapping results may be invalid. The quality group of the establishment should be aware of the changes and their possible impacts and should assess whether it is necessary to update. In general, We advise the customer to re-conduct the mapping, If there are invasive changes. Changes such as HVAC unit replacement, Reconstruction of the area (Storage) or after five years. It is important to assess any changes that have arisen, In order to ensure the quality and safety of products at any time.
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Source: Sensitech®