Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Temperature Control for Ambient Medicinal Product Storage
Temperature Control: Why is it important?
Storing and transporting medicinal products at the right temperature is essential for ensuring their quality, safety and efficacy.
Medicinal products are sensitive to temperature changes and may be compromised if exposed to extreme or inappropriate conditions, rendering the products as unsuitable for patients. Therefore, it is important to follow the guidelines and regulations on good distribution practice (GDP) for medicines, which include the requirements for environmental awareness and potentially control.
What are the temperature ranges for ambient products?
Ambient products are those that do not require refrigeration or freezing, but still need to be stored and transported within a certain range. The label or outer packaging of the product should indicate the specific storage conditions, such as “store below 25°C, do not refrigerate” or “store between 15°C and 25°C”. If there are no specific requirements, the product can be stored at any temperature between 8°C and 30°C, which is the general definition of “ambient”.
It is arguable that product can ship between 2°C and 8°C if listed as store below 25°C and store below 30°C, however you need to be aware of the potential for condensation (liquid formed when a gas or vapor cools and changes state), which can lead to packs sticking to each other, ink running or packaging becoming warped.
However some products may have different ranges, depending on the manufacturer or the market authorisation holder. For example, some test strips, oncology products and hospital lines may have a narrower range of 15°C to 25°C as per US Pharmacopeia, 20°C, +/- 5.
It is therefore vital to the quality and integrity of the product that pharmaceutical distributors check the label or packaging of each product before storing or transporting it. If there is ambiguity with regards to the storage conditions of the product, consult with the Marketing Authorisation holder for clarification.
How to optimise temperature control in storage areas
Storage areas for ambient products should be temperature mapped, qualified and validated to ensure that they provide suitable conditions for the products to be stored. Temperature mapping is a process of measuring and recording the temperature variations in a storage area over a given period of time, typically a working week. This helps to identify any hot or cold spots, as well as the average and maximum temperatures in the area.
Based on the results of the mapping, storage areas can be optimised to ensure the temperature suitability for the products stored.
Temperature mapping exercises should be repeated periodically to ensure conditions are maintained during winter and summer months. Temperature monitoring devices, such as calibrated thermometers or data loggers, should be used to regularly check and record the temperature in the storage area.
You should also consider that the hottest and coldest spots may be suitable for products with a broader label condition, or to store packing materials, pallets etc that are not temperature sensitive.
In the latter case you should then pick the next hottest or coldest points for storing medicines, to reduce the risk of excursion during extreme weather conditions.
Equipment Maintenance
If you have equipment to maintain the temperature and environment in the storage areas then the Responsible Person (RP) or warehouse management need to ensure that regular servicing and maintenance checks are in place and the equipment is serviced and any faulty parts or filters (more in GMP than GDP) are replaced.
It is recommended that a maintenance log is maintained to keep track of equipment maintenance and servicing. This would be an outsourced activity where specialist engineers will take care of this, and a Service Level Agreement (SLA) or possibly a Quality Technical Agreement (QTA) should be in place, depending on what activities take place.
A written report must be provided and reviewed by the RP or a suitably trained individual and filed as evidence that such maintenance has been undertaken. This forms part of your QMS and is required GDP documentation.
You should recognise that any major service or relocation of equipment will require a risk assessment and possibly a complete re-map.
How to ensure temperature control during transportation
The transporting vehicle of ambient products should be considered as an extension of the storage area, and therefore follow the same principles of temperature control. Products should be transported under label conditions or within the boundaries of the market authorisation. This means that products should not be exposed to temperatures outside their specified range during transit.
To achieve this, various methods are employed such as using temperature-controlled vehicles or couriers, validated shippers or containers, passive or active cooling systems, thermal blankets or insulation materials. The choice of method depends on the type and quantity of products, the distance and duration of transportation, the external weather conditions and the cost-effectiveness.
Remember that pre-validated shippers MUST be validated by you also, you cannot use off the shelf validation, unless it has been tested on the lane you are proposing to use.
If the vehicle to be used for transporting the goods is not environmentally controlled, a Risk Assessment must be carried out.
The risk assessment should cover the whole route, any obstacles on the journey such as roadworks, the weather (as this can change dramatically over a long distance), security, transit hubs, careful consideration of the vehicle’s payload area etc. It is the responsibility of the supplying wholesaler to ensure that the goods reach the end customer (not the port, or airport, or neighbours premises) within expected temperature ranges, and this should be evidenced by logger data or suitable historic data of similar journeys during your qualifications. Whatever happens, the condition of the medicines and patient safety are your top priority.
Transport validation exercises should be performed prior to transporting medicinal products for the first time and repeated periodically to assess the temperatures of medicinal products during winter and summer months.
What are the consequences of failure to control temperature?
Failure to control temperature during storage or transportation can have serious consequences for both the quality of the medicincal products and the safety of the patients who take them. Products that are exposed to temperatures outside their specified range may degrade, deteriorate or become contaminated. This can affect their potency, stability, appearance or performance. As a result, they may not work as intended, or a component within the medicine may become damaged i.e; the slow-release component within a tablet may be compromised thus the API is released in the patient to quickly or too early, causing adverse reactions in patients.
Product recalls may be implemented in cases whereby patient safety has been compromised.
The Cost of Failure
Failure to control temperature would lead to regulatory action, such as shortened inspection periods, referral to the IAG, suspension or drug recall. Any of these can damage the reputation and credibility of the wholesaler, distributor or supplier involved in the supply chain. Moreover, potentially heavy financial losses due to wasted products, legal liabilities or compensation claims could occur, which could be business ending.
Therefore, it is vital to follow the GDP guidelines and regulations on temperature and environment control for ambient medicinal products. This will increase the likelihood that the products are stored and transported under appropriate conditions and reach their intended destination in a safe and effective manner.
Conclusion
A failure in temperature and environmental control in a facility storing medicinal products can be prohibitively expensive and damaging to the wholesaler. Regular maintenance and temperature recording is an absolute priority, to ensure the storage area is maintained within a required range at all times, regardless of the weather outside.
Assistance and Support
Paradigm Shift Consulting Ltd is an ISO 9001:2015 certified consultancy providing training and quality management services to the pharmaceutical industry.
We can help you with your temperature management needs by:
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- Reviewing your existing environmental management system and identifying gaps or areas for improvement.
- Performing temperature mapping exercises of your storage areas.
- Assisting you in writing or updating your quality manual, SOPs and records in line with the current regulations and guidelines.
- Conducting validation activities for your equipment, systems and processes.
- Managing change control processes for your quality system or GDP operations.
- Providing training on warehouse storage management and Good Distribution Practices for your staff.
Our team of experienced consultants can support you as contract Responsible Persons (RPs), Quality Managers, Lead Auditors, RPi’s and interim managers. We can also conduct supported self-inspections of your site or audit your nominated third-party logistics providers (3PLs), following MHRA inspection protocols.
If you are interested in our services or have any questions about temperature mapping or GDP compliance in general, please contact us for a free, short consultation over the phone on 0330 133 0920. Alternatively, you can email on info@paradigmshiftconsulting.co.uk or use the contact form below.
If you have additional details to advise us about and require a more in-depth response, you can use our executive contact form.
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