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
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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.
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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.
Information Security Management Systems
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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.