With growing demand for GLP-1s, their supply chain integrity is vital. This article shows how EU Good Distribution Practice (GDP) and data operations (DataOps) help people manage these temperature-sensitive medicines in Europe.
GLP-1s: Temperature Control
GLP-1 drugs, for diabetes and obesity, are showing promise for other conditions, increasing demand. Global sales hit $53.6B (approximately £42.34B / €49.31B) in 2023, projected to reach $119.8B (approximately £94.64B / €110.22B) by 2030, straining logistics.
Note: All currency conversions are approximate and for illustrative purposes, based on hypothetical exchange rates of 1 USD = 0.79 GBP and 1 USD = 0.92 EUR.
These time- and temperature-sensitive drugs need 2–8 °C storage. Maintaining this is basic for efficacy and safety. Deviations degrade products, impacting effectiveness or causing harm. High prices amplify financial risks. For GLP-1s, robust temperature management, supported by reliable data, is a core business imperative, safeguarding financial viability, patient well-being, and reputation.
EU GDP Principles
GDP guidelines govern pharma transport and handling, enforced by the European Medicines Agency (EMA) to ensure quality. The guidelines detail EU distribution requirements. Core principles include strict temperature control, calibrated equipment, continuous data monitoring, risk management, and training. GDP for Active Pharmaceutical Ingredients (APIs) ensures consistent quality. GDP’s flexibility allows tailored control via detailed risk assessments. Constant monitoring isn’t always needed if routes are assessed. This shows GDP as a risk-based system, promoting data-driven control and empowering people to manage their own processes. Data-supported risk assessment is a key compliance tool.
| Category | Requirement | Relevant GDP Chapter & Snippet Reference |
| Premises (Storage) | Initial Temperature Mapping must be conducted under representative conditions before use. | Chapter 3.2.1 |
| Repeat Mapping is required if a risk assessment indicates necessity or following significant facility/equipment changes. | Chapter 3.2.1 | |
| Monitoring Equipment Placement must be based on mapping results, in areas of extreme fluctuations. | Chapter 3.2.1 | |
| Small Premises require a risk assessment for monitor placement (e.g., considering heaters). | Chapter 3.2.1 | |
| Transportation | Required storage conditions must be maintained throughout transport. | Chapter 9.2 |
| Deviations (e.g., temperature excursions) must be reported to distributor and recipient. | Chapter 9.2 | |
| A procedure for investigating and handling temperature excursions is essential. | Chapter 9.2 | |
| Vehicles and equipment must be suitable and appropriately equipped to prevent quality compromise. | Chapter 9.2 | |
| Written procedures for vehicle/equipment operation and maintenance are required. | Chapter 9.2 | |
| Risk assessment of delivery routes determines where temperature controls are needed. | Chapter 9.2 | |
| Monitoring equipment during transport must be maintained and calibrated regularly (at least annually). | Chapter 9.2 | |
| Dedicated vehicles are preferred; if non-dedicated, procedures must ensure product quality. | Chapter 9.2 | |
| Transit storage facilities require attention to temperature monitoring, cleanliness, and security. | Chapter 9.2 | |
| Temporary storage duration during transit should be minimised. | Chapter 9.2 | |
| Equipment | Design, location, and maintenance must be suitable for intended purpose. | Chapter 3.3 |
| Key equipment requires planned maintenance. | Chapter 3.3 | |
| Calibration at defined intervals based on risk/reliability assessment, traceable to national/international standards. | Chapter 3.3 | |
| Appropriate alarm systems for condition exceedance, correctly set and regularly tested. | Chapter 3.3 | |
| Repair, maintenance, calibration must not compromise product integrity. | Chapter 3.3 | |
| Adequate records of repair, maintenance, and calibration activities must be kept. | Chapter 3.3 |
Premises Temperature Control
GLP-1 integrity begins in static storage. EU GDP mandates strict environmental controls, requiring distributors to monitor temperature, light, humidity, and cleanliness using appropriate equipment and procedures. Initial temperature mapping of storage areas identifies extreme zones, helping staff know where to place monitoring equipment for accurate data. This data-driven process evolves, requiring re-mapping if risk assessment or facility changes necessitate. This allows teams to maintain continuous validation in dynamic environments. Risk assessment also guides monitor placement for smaller premises, considering factors like heaters.
Maintaining Conditions in Transit
Transporting medicines is challenging. EU GDP requires maintaining storage conditions throughout transit. Data-reliant procedures for handling excursions are essential, ensuring staff can act on deviations promptly. Distributors must ensure vehicles prevent product compromise. Risk assessment of delivery routes helps logistics teams plan for travel duration, weather, and vehicle types. This informs where temperature control is needed. The Medicines and Healthcare products Regulatory Agency (MHRA) views transportation as an extension of storage, so teams must manage vehicles and transit hubs with warehouse-level care. Real-time data informs adaptive logistics, helping people make quick decisions.
Equipment: Calibration & Monitoring
Reliable equipment is fundamental for temperature control. EU GDP requires that all storage and distribution equipment is appropriately maintained. Monitoring equipment must be calibrated regularly, with data traceable to national standards to ensure accuracy. Alarm systems signal condition exceedance, enabling rapid intervention and mitigating risk through timely data. Digital records for key equipment are essential for a complete audit trail. Dataloggers provide vital temperature data for quality release. This focus on calibrated equipment and data-driven alarms empowers personnel with the tools for a proactive, preventative approach.
Proactive Risk Mitigation
Effective temperature excursion management relies on proactive strategies and robust GDP risk management. Risk assessment guides transport controls and monitor placement , aligning with Quality Risk Management (QRM) principles. Mandatory procedures for investigating and handling transport excursions are driven by data analysis. The MHRA discourages Mean Kinetic Temperature (MKT) unless provided by a Marketing Authorisation (MA) holder. This regulatory preference for direct, verifiable data helps staff avoid relying on statistical averages that can mask severe excursions. Real-time visibility solutions provide crucial data on product location and condition, enabling staff to make data-driven interventions.
Training & Documentation
The human element and meticulous record-keeping underpin GDP compliance. Proficient personnel are vital, requiring comprehensive training on handling, documentation, and data monitoring. Operational training on insulated box assembly and cool-pack reuse shows how detailed instruction prevents excursions. Meticulous documentation creates an essential audit trail. Records of temperature, deviations, and labelling must be kept for five years. Daily min/max temperature recording is needed at all storage locations, and distributors must review data and have corrective action procedures. A Quality Management System (QMS) is only as strong as its human element and the integrity of its data records, highlighting the importance of empowering staff with reliable tools and processes.
Robust Quality Systems
GDP compliance requires an integrated QMS that treats the supply chain as a continuous, controlled environment. This helps everyone manage temperature excursions and leverage data for insights. A key principle is proactive risk identification and mitigation, informed by data. Outsourced transport contracts must incorporate GDP Chapter 7 (Outsourced Activities). The MHRA’s view of “transportation as an extension of storage” reinforces a single chain of custody reliant on data. A comprehensive QMS ensures smooth handovers, consistent quality, and rapid, data-informed response, helping people across the business perform their jobs reliably.
In summary
Growing demand for GLP-1s makes rigorous temperature control a business imperative. EU GDP provides the framework, positioning temperature management as a process for people to use effectively. GDP is a risk-based QMS that relies on data-driven assessments. Storage mapping and transportation are evolving processes demanding careful, data-informed control. Emphasis on equipment, calibration, and alarms provides a preventative approach, enabling staff to detect deviations early. The regulatory stance on MKT prefers direct, verifiable temperature data, stressing detailed records. Ultimately, effective temperature control relies on well-trained people and meticulous data management. An integrated QMS is vital, treating the supply chain as a continuous, controlled, data-rich environment that helps everyone safeguard product quality and patient safety.
The blend of competencies available from the team at Maly IT Solutions is exceptionally well suited to helping you. Whether your organisation requires assistance on short- or long-term basis, you will find Maly has the deep technical, process management, quality management and compliance expertise you are looking for.
References
- (https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52013XC112301&from=EN)