To guarantee the appropriate quality of medicines for end users, it is necessary to comply with the requirements for manufacturing and distribution. These are covered by standard EU GDP – Good Distribution Practice.
Requirements for good distribution practice are based on legal requirements of the Czech Republic (Decree No. 229/2008 Sb., on the manufacture and distribution of medicines) and Guidelines of the European Commission on Good Distribution Practice of Medicinal Products for Human Use (Directive 2013/C 343/01).
Certification for good distribution practice is recommended to all companies involved in the supply chain in the pharmaceutical industry.
Requirements of GDP
- Provision of a delivery note containing all the necessary information
- Appropriate conditions for storage and transportation of medicines
- Proper record-keeping to ensure traceability of information
Benefits of the Certification
- You will get an internationally recognized certificate
- Compliance with requirements of the standard
- Compliance with EU requirements for storage and distribution of medicines
- Greater trust of customers and end users
- Well-proven quality of medicines, from manufacturing to distribution
The most requested certification
Quality Management Systems
As the competitiveness of business environment grows, clients demand greater quality of goods and services. Standard ISO 9001 has been developed by International Organization for Standardization (ISO) with the aim to implement the international standardized system for quality management. Quality management systems in compliance with ISO 9001 will enable you to improve the quality of your goods and services, to make your company procedures more efficient and it will also allow you to participate in procurement procedures announced by public administration bodies. Standard ISO 9001 is one of the best known and most widely used international standards. This certification is recommended to organizations of any size or sector whose activities include production or provision of services.
Environmental Management Systems
If you care about the environment, you should seek to adapt your relevant company processes to management systems based on the internationally recognized standard ISO 14001. The certification based on ISO 14001 will enable you not only to fully control the impact your company has on the environment, but it will also help you reduce operational costs in an efficient way. Moreover, your company will get better awareness of environmental issues. The certification for ISO 14001 is recommended particularly to manufacturing companies of any size or sector that wish to take control of their environmental impact. At the same time, you can combine it with the certification for ISO 9001 to get an integrated management system.
Management Systems of Occupational Health and Safety (OHS)
Occupational safety is an integral part of successful business activities. The internationally recognized standard ISO 45001 aims to improve occupational safety and protection of health at work, while also minimizing the risk of occupational diseases. Standard ISO 45001 has fully replaced the original standard OHSAS 18001. By implementing this standard, you will be able to achieve an enhanced occupational safety, to prevent occupational diseases and, the last but not least, to minimize the risk of business interruption in your organization. Prevention is always cheaper than remedy. The certification for ISO 45001 is recommended to all companies that seek to improve safety of processes for all their workers. ISO 45001 can be integrated together with standards ISO 9001 and ISO 14001.
Information Security Management Systems
Business Continuity Management Systems
IT Service Management Systems (ITSM)
Would you like to learn more about certification for good distribution practice in your organization? Please contact us and we can provide it.