At CC Pharma, we are continuously expanding our technical resources for the systematic monitoring of drug safety. In our view, quality focus according to legal regulations in line with GDP and GMP guidelines and pharmacovigilance are essential prerequisites for minimising risks. Ensuring the safety of our pharmaceuticals is a core element of our entrepreneurial responsibility. We therefore take continuous action to minimise hazards and regularly improve our quality standards.
This also includes actions in the field of supplier management to ensure the high standard of our supply chain. We also perform regular on-site risk analyses, inspections and supplier audits.
Quality assurance is the basis of our production
Production permit according to Section 13 AMG
Wholesale permit according to Section 52a AMG
Quality assurance according to GMP and GDP guidelines
BTM permit according to Section 3 BtMG
In addition, our quality management system is certified according to DIN EN ISO 9001:2008
We take physical reference samples
Risk-based qualification of suppliers/carriers and on-site audits
Good documentation, in the form of standard operating procedures (SOPs), work instructions, risk management and non-conformity management for all processes in our company, is an important part of our quality system. In addition, we apply the Change Control system for change management. The system is used for evaluating all changes in the company that might impact on the production and quality of a product. To ensure the safety of imported pharmaceuticals, CC Pharma engages in various further actions and applies two further systems:
CAPA (Corrective and Preventive Action): A solution that identifies non-conformities and defines continuous improvement actions for process alignment.
Initiative Securpharm: An individual data-matrix code is provided on pharmaceutical packaging, aimed at improving the future safety level of pharmaceuticals.
Official launch: the system will be mandatory from February 2019 onwards and is expected to launch in late 2018.
Pharmacies will verify the code before handing over pharmaceuticals to patients.
More information: www.securpharm.de
For questions related to quality assurance, please do not hesitate to contact our qualified persons, Dr. Markus Daniel and Dr. Kathrin Schwall, who will be happy to assist you.
Email us or simply call us at:
Tel.: +49 (0) 6594 9219-220
Fax: +49 (0) 6594 9219-400
We will also be happy to call you back.