…for all participants in the pharmaceutical supply chain quality management plays a key role in operations. Quality management includes the assurance of a full compliance with the applicable regulatory guidelines, such as the Good Manufacturing Practice (GMP), the Good Distribution Practice (GDP) or the Good Clinical Practice (GCP), as well as adherence to the national laws and regulations and relevant industry standards (ISO) …

For all participants in the pharmaceutical supply chain quality management plays a key role in operations. Quality management includes the assurance of a full compliance with the applicable regulatory guidelines, such as the Good Manufacturing Practice (GMP), the Good Distribution Practice (GDP) or the Good Clinical Practice (GCP), as well as adherence to the national laws and regulations and relevant industry standards (such as ISO 9001, ISO 14 001, ISO 50 001). In addition, it also entails strictly meeting all requirements of European directives, regulations and other forms of legislation, such as the Falsified Medicines Directive (FMD) implemented in 2019 or the Medical Devices Regulation (MDR) planned to be implemented in 2020.

For all participants in the pharmaceutical supply chain quality management plays a key role in operations. Quality management includes the assurance of a full compliance with the applicable regulatory guidelines, such as the Good Manufacturing Practice (GMP), the Good Distribution Practice (GDP) or the Good Clinical Practice (GCP), as well as adherence to the national laws and regulations and relevant industry standards (such as ISO 9001, ISO 14 001, ISO 50 001). In addition, it also entails strictly meeting all requirements of European directives, regulations and other forms of legislation, such as the Falsified Medicines Directive (FMD) implemented in 2019 or the Medical Devices Regulation (MDR) planned to be implemented in 2020.

Companies wishing to engage in pharmaceutical wholesaling activities should first acquire a Wholesale Distribution Authorization (WDA) from the national regulatory authorities. Our company frequently assists its partners in such endeavour by providing the below listed quality management related services:

• Assistance in selecting the correct type of Wholesale Distribution Authorization (WDA) based on the business needs, product portfolio, partners and processes of the applying company;
• Assistance in selecting the correct type of Wholesale Distribution Authorization (WDA) based on the business needs, product portfolio, partners and processes of the applying company;
• Provision of quality management personnel including the Responsible Person to be named on the WDA application;
• Assistance in the administrative procedures (contracts, verification documentation, etc.) pertaining to the selection of business partners, suppliers and vendors;
• Assistance in managing any additional documentary requirements to resolve discrepancies or provide corrections as requested by the regulatory agency after the submission of the WDA application;
• Provision of an inventory management system that is duly connected to the required databases within the European Medicine Verification System (EMVS) and equipped with a remote access function allowing the applying partner to manage certain inventory actions offsite;
• Assistance during the regulatory inspection conducted at the warehousing facility of the applying partner.

The successful acquisition of a WDA is also subject to finding an operational base locally or establishing a relationship with an existing logistics service provider. Our company allows several business partners to use its facilities as a logistics base in Hungary while offering the following quality management related services:

• Provision of quality management personnel including the Responsible Person to be in charge of all quality management processes;
• Physical management of incoming consignments (qualitative and quantitative checks, sampling, etc.) arriving from international or local manufacturing facilities;
• Review and handling all logistics and quality management related documentation pertaining to incoming consignments arriving from international or local manufacturing facilities;
• Quality management of the entire order fulfilment process including all elements of picking, reviewing, packing and delivery of the outgoing consignments;
• Execution of all processes related to the Falsified Medicines Directive (FMD) including product data upload, verification, decommissioning and alert management;
• Assistance regarding all quality management related processes, such as the handling and documenting product recalls, returns, complaints, deviations, corrective and preventive action, etc;
• Assistance regarding all quality management related processes, such as the handling and documenting product recalls, returns, complaints, deviations, corrective and preventive action, etc;