GDP-Compliant Transportation of Pharmaceuticals Pharmaceutical Logistics – Get GDP Into Motion
Continuous documentation, qualified vehicles, staff training: the EU guidelines on “Good Distribution Practice” (GDP), amended in 2013, impose significantly greater obligations on manufacturers and freight forwarding companies dealing with pharmaceutical products. They transfer the already familiar principles of the Good Manufacturing Practices (GMP) from pharmaceutical manufacturing onto the streets.
The current version of the long awaited amendment to the EU-GDP dated 7th March 2013 has been in force since 24th November 2013. The amendment to the EU guidelines replaced the European regulations for the transport of medicines from 1994. The guidelines are divided up into the following ten chapters: Quality Management, Personnel, Premises and Equipment, Documentation, Operations, Complaints, Outsourced Activities, Self-inspections, Transportation and Specific Provisions for Brokers.
Along with the GMP, the amendment to the GDP now sets higher legal standards for the storage and distribution of medicines. Implementation is also regulated by Article 7 of the Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV, Regulations on the production of pharmaceuticals and active substances) and Article 1a of the Verordnung über den Großhandel und die Arzneimittelvermittlung (AM-HandelsV, Regulations on the retailing and procurement of medicinal products). Both regulations were derived from the already well-established and internationally applicable WHO GDP guidelines.
What does GDP 2013 entail?
Stricter regulation, in particular for the transportation of pharmaceuticals, was long overdue, as the theft and counterfeiting of medicines are rapidly becoming more widespread in Europe and worldwide. Added to this is the fact that an increasing number of highly sensitive hi-tech medicines such as bio-pharmaceuticals are being developed, which are particularly sensitive to temperature and correspondingly demanding with regard to storage and transportation.
Since 2013 the GDP guidelines have imposed significantly stricter obligations on the manufacturer as the consignor and on its logistics service provider. These are the most important criteria and requirements from the GDP guidelines:
- The storage and transportation of medicinal products must comply with the temperature requirements listed on the packaging.
- Deviations during conveyance must be reported to the contract giver.
- The driver and all those involved in the process must have received GDP training.
- Standard Operating Procedures (SOP), that is to say procedures for dealing with vehicles and equipment, must be drawn up.
- The recipient is entitled to request the temperature printout during transportation.
- Temperature-controlled vehicles: the temperature must be mapped and maintenance and calibration of the temperature mapping equipment must be undertaken annually.