What is Good Distribution Practice (GDP) in Pharma?
Within the pharma and medical industry, Good Distribution Practice (GDP) is used as a quality and safety standard to ensure that high-value products are stored, transported, and handled correctly.
According to EMA, in order to comply with GDP in the pharma industry, all stakeholders should ensure that:
- “medicines in the supply chain are authorized in line with European Union (EU) legislation;
- medicines are maintained in the right conditions at all times, including during transportation; contamination by or of other products is avoided;
- an adequate turnover of stored medicines takes place;
- the right products reach the right recipient within a satisfactory time period.”
Further, they state that not only are the distributors required to hold the correct licenses to comply with national legislation, but any single person involved with the distribution process should be trained adequately on GDP.*
*For more information on training, visit ECA GDP Association or the ECA Academy.
Understanding GDP Requirements
So what measures are in place to protect product quality? GDP outlines the following three areas that need to be adhered to in the legislation.
Facility Design and Layout
GDP states that within the facility design and layout, it is necessary to ensure that there are specific temperature zones that maintain a variety of temperatures, such as chilled, ambient, and frozen, if required.
Additionally, it’s advised to have designated areas for quarantine, waste, and stock materials to prevent cross-contamination.
The legislation places an emphasis on keeping regular records. Therefore, ensuring the temperature, stability of the internal environment, and airflow systems are regularly monitored and recorded is required.
Lastly, regarding the facility requirements, access control is paramount. Utilising physical locks or key cards for facility security measures will ensure that only authorised personnel can access or handle the sensitive products.
Refrigeration Units and Cooling Systems
Due to the high-value and high-risk nature of the pharma industry, GDP emphasises that all equipment used in the facility should be designed to maintain the specific requirements set out by insurance companies and larger bodies.
As for the conditions of the medical cold storage build themselves, the GDP ‘Good storage and distribution practice for medical products’ report includes recommended temperature storage conditions:
Table A7.1*
Recommended limits for descriptive storage conditions
| Label description | Recommended limits |
| Store at controlled room temperature | 15 to 25 °C |
| Store in a cold or cool place | 8 to 15 °C |
| Store in refrigerator | 5 ± 3 °C |
| Store in a freezer | –20 ± 5 °C |
| Store in a deep freezer | –70 ± 10 °C |
| Store in a dry place | No more than 60% relative humidity |
| Protect from moisture | No more than 60% relative humidity |
| Store under ambient conditions | Store in well-ventilated premises at temperatures of between 15 °C and 30°C and no more than doing 60% relative humidity. Extraneous odours, other indications of contamination and intense light must be excluded. |
| Protect from light | To be maintained in the original manufacturer’s light-resistant containers. |
| Chilled | 5 ± 3 °C |
*These limits are recommended values and are based on pharmacopoeia limits and guidelines.
However, as part of the GDP requirements, not only should the facility have the required equipment installed, but fail-safe systems should be in place in case of any faults that arise. They suggest that this could include backup cooling units, emergency generators, and alternative power supplies. For instance, this could be in the form of N+1 redundancy and HVAC systems.
Lastly, the GDP report outlines that not only should the refrigeration units be continuously assessed to identify any potential issues, but the premises, stock control & rotation, and general equipment should all undergo rigorous risk management and assessment.
Temperature Monitoring and Control Systems
To aid in the risk management assessment, there are systems required as part of GDP to ensure the safety of the products and temperature-sensitive equipment.
To begin, they state that real-time temperature monitoring systems, such as data loggers and sensors, should be installed. Secondly, alarm systems, whether local or remote, should be in place in case of temperature excursions. Lastly, the facility should undergo temperature mapping to aid in identifying potential hot or cold spots across the designated area.
At CREST, once a client’s facility GDP specifications and regulations are outlined, we work with clients to ensure that the design and build of temperature-controlled areas adhere. Our team’s expert knowledge comes from a passion to continue learning and keeping up to date with any new or amended GDP legislations.
Mark Kendrick, CREST’s controlled environment specialist, has extensive experience in pharma cold storage solutions and is available to discuss your project needs.
You can reach out to Mark at 07585 301425 or send us an enquiry.
Further reading:
PIC/S HUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS
Medical devices – Quality management systems – Requirements for regulatory purposes
