Good Distribution Practice (GDP) Pharma

Correct storage and transport of medicines aiming to preserve their quality, efficiency and non-harmfulness are necessary during the entire distribution process. Cold chain comprises the overall transport of medicines, from manufacturer to end users, and specially important is to prevent incorrect handling of medicines in transport, which can have a negative impact on quality, efficiency or safety of medicines.

Good Distribution Practice (GDP) is an integral part of quality assurance in RALU Logistics, which enables consistent storage, transport and handling of medicines under appropriate conditions, as prescribed by marketing authorization (MA) or product specification.
There are numerous dangers that can undermine quality during the distribution process, from cold chain undermining, unauthorized storage, theft, goods defects, poor hygiene, lack of protection from weather conditions, lack of temperature control, cross pollution, non-compliance with ADR rules to providing false and incomplete documentation.

European guidelines for GMP help in preventing undesired circumstances and in quality product preservation, and specially important are other regulations as well: GDP Act (Good Manufacturing Practice, the current version from March 7, 2013), EMA control (European Medicines Agency) and European laws translated into national laws (GDP in Germany within AMG (Medicinal Products Act)).

Guidelines for quality preservation comprise three important procedures:
  1. Calibration of trailers
The process is applied in the field of Ralu Logistics' transport, storage and distribution services. GDP PHARMA System leader and goods managers are responsible for regular annual calibration of sensors of measuring instruments in trailers, distribution vehicles and warehouses. Leaders working in other fields are responsible for planning and implementing measurement procedures complying with GDP PHARMA System Guidelines. Drivers are entitled to report all malfunctions of sensors in trailers or laser thermometer.
Each trailer should have a valid ATP Certificate (according to FRC Standard).
  1. Employees training
Staff and education planning is a part of the process of creation of Ralu Logistics' business plan. This includes planning the number of employees, staff expenses, number and type of education, education costs for business functions. Those employed in the field influencing service quality should get their jobs as appropriate, based on their education, professional training, skills and gained experience. Specially important is to follow RALU Logistics' staff education with regard to topics from the field of pharmaceutical quality and products safety.
  1. Cleaning/disinfection and temperature regime
These processes describe cleaning of trailers or trunks, in order to prevent microorganisms contaminating the goods in transport. There is also a strictly prescribed temperature regime for transport of medicines and pharmaceutical products.

Medicines require lots of attention and clearly defined processes. Special attention should be given to temperature, hygiene and documentation. Any deviations and activities which are not in accordance with relevant regulations, guidelines and acts should be reported.

Na Vrh Print Pošalji prijatelju