Good Distribution Practice – together we care about quality/ because we care
mgr farm. Joanna Kaczmarczyk
According to the records of Good Distribution Practice (in short GDP), entrepreneurs working with medicinal products are recommended to implement, monitor and maintain the Quality Management System. The system, which is an integral part of GDP, should be adapted to the size and characteristics of a particular company, which optimizes all the processes that make up the whole operation of the business.
On June 19, 2016 r. a revised regulation of the Minister of Health on the requirements of the GDP was announced. Up to 20 September. entrepreneurs were obliged to adapt their operations to the new requirements of the Regulation. According to new rules of GDP entrepreneur leading pharmaceutical wholesaler is obligated to employ a certain number of competent, trained personnel in order to perform tasks related to the trade in medicinal products. In addition, the entrepreneur chooses the Responsible Person which has an access the key resources and has all the powers necessary to perform the duties specified in GDP, including the delegation of certain tasks to company’s employee.
The amendment of GDP has changed a number of specific requirements for storage conditions, for rooms in warehouse, distribution of medicinal products, supplements, cosmetics, medical devices, etc. and validation of the IT system. GDP requirements put a significant changes on pharmaceutical businesses for receiving/accepting returns of cold chain products in particular. in case of a derogation, it is necessary to demonstrate the integrity of the medicinal product by carrying out a risk assessment.
According to current requirements of GDP an entrepreneur running the pharmaceutical wholesale has many responsibilities regarding the documentation, for example:
- documentation should include appropriate procedures, instructions, contracts and records;
- the trader provides an immediate access to the documentation or the possibility of its immediate restoration on request of an authorized persons;
- documentation covers the whole range of activities and is conducted in Polish, however some exceptions were allowed
Currently the entrepreneur is obliged to carry out the wholesale internal controls aimed at monitoring the implementation and enforcement of GDP. These audits should be done fairly by the designated, trained workers of the company. In addition, it is recommended to carry out audits done by independent external experts, however, these audits must be based on certain principles and should not replace the internal controls.
The above examples of changes made in the subject of GDP, create the need for pharmaceutical warehouse to verify the total number of processes and procedures. This applies especially to warehouse managers and executives as they are responsible for maintaining the quality and control of the business. Taking an appropriate early action allows you to adjust your business to the requirements of warehouse GIF control, especially now, as the timetable for the audit Inspectorate for 2017 has already been published.