Following the entry into force of the new European Guidelines on Good Distribution Practice for drugs for human use, the logistics industry is necessarily adapting quickly and inexorably to the new demands of the pharmaceutical industry.
The EU GDP Guidelines were created in order to regulate the human use of the drug distribution activities, to maintain the quality of the product up to the patient and manage the traceability of the same in order to combat counterfeiting. The GDP are intended to regulate an important part of the supply chain of drugs for human use, going to impact on the work of the drug distributor, as well as on the so-called last mile.
All the actors of the distribution process are reviewing their processes in order to apply with good distribution practices. For this purpose IATA (International Air Transport Association) has developed a certification that is based on the fundamental of GDP and WHO guidelines (World Health Organization).
The IATA CEIV certification (Center of Excellence for Independent Validator) consists of two training events held by the IATA qualified instructors, for the achievement of the "IATA pharmaceutical diploma", called:
1. Temperature Controlled Cargo Operations;
2. Audit, Quality and Risk Management for Temperature Controlled Cargo
and two audits conducted by Independent Validators, industry experts, who through an initial on-site assessment will identify the compliance areas with the IATA certification requirements and the "non compliance" areas issuing a Gap analysis. The second inspection is the final validation and it is intended to ensure that all the requirements of IATA CEIV certification have been met. The customer, prior to final validation will have regularized all non-conformities detected during the first audit.
The main business sectors involved in the certification are:
- Quality Management System;
- Personnel Management;
- Documentation regarding the processes (internal and external);
- Infrastructure & Premises (cold storage, mapping, calibration, container management etc);
- Operating Activities (tarmac track transport, warehouse activities etc);
- Ground transportation (goods vehicle activity);
- Complaints and Self Inspection management;
- Supplier Management
Depending on the organizational structure of the company, the certification process can vary in time and impact on activities of daily work.
MDG Consulting has actively contributed to the creation of this innovative IATA certification and can represent for the customer a valuable partner during the whole certification process.
Thanks to the experience gained in several projects, such as the certification of the two most important Italian cargo airports, Milan Malpensa and Rome Fiumicino by the certification of Bcube Air Cargo and the certification of the air carrier Cal Cargo of Liege, MDG Consulting can support and assist clients in the development process and the completion of non-compliances.
MDG Consulting provides consulting services in the GDP and IATA CEIV certification, such as:
- Documentation drafting complies with GDP (quality manual, operational procedures ...);
- Development of Risk Assessments;
- Cooling room mappings;
- Temperature monitoring systems ...;
- Training material;
MDG Consulting entrusts its highly qualified personnel services that will handle the project with professionalism, always keeping in mind the needs of the customer and will act as an intermediary with the IATA, in gaining together with her customers as soon as possible to the common goal, the certification IATA CEIV!