Quality
Continuous monitoring and improvement of processes
Quality
All drugs imported by CC Pharma come from the same domestic and foreign pharmaceutical companies as the preparations already familiar to patients. They are therefore exclusively originals that are made marketable by CC Pharma for the German market. In detail, this means: all relevant information is translated for the patient, labels are applied and package inserts are added.
This enables us to provide the German healthcare market with cheaper branded preparations of the same quality.
CC Pharma has a manufacturing authorization in accordance with Section 13 (1) and Section 72 (1) of the German Medicines Act (AMG) and is therefore subject to the same regulatory supervision as the original manufacturer.
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 risk minimization. Ensuring the safety of our pharmaceuticals is a core element of our entrepreneurial responsibility. We therefore take continuous action to minimize hazards and regularly improve our quality standards.
CC Pharma stands for reliable quality assurance that goes far beyond the legal requirements. For us, this begins long before the drugs even arrive. As a drug importer, we have a large supplier network that has proven itself over many years. In addition, we regularly expand our technological and human resources to ensure seamless, systematic monitoring of the supply chain. All suppliers are subjected to an extensive qualification process, which also includes risk-based auditing of the respective supplier. This enables us to convince ourselves of the quality of the storage and the products directly on site.
As soon as medicines arrive at our facility, they are first subjected to an extensive incoming goods inspection. Hidden safety features and the further internal handling of the goods are also checked. This is because our comprehensive quality management system naturally also includes internal process reliability.
After the incoming goods have been inspected, all packaging materials are then prepared and checked. This marks the beginning of the actual production process, during which a German package insert is added and the secondary packaging is manufactured for the German market. The manufactured pharmaceuticals are then subjected to a final inspection and, after release by the qualified person, are prepared for shipment. From there, the products are shipped to pharmacies and wholesalers. Quality assurance is carried out by means of a holistic control system throughout the entire process.
Quality assurance in accordance with GMP and GDP guidelines includes, among other things:
Important components of internal process safety are the provision and maintenance of work instructions and sufficient documentation. We use a risk-based change control system to evaluate and control all process-relevant changes in the company. In a continuous improvement concept, so-called “CAPAs” (Corrective and Preventive Action) for process optimization are assigned to each error that occurs. In addition to internal process safety, regular external inspections of our supplier network are also part of our holistic control system.
To ensure the safety of imported pharmaceuticals, CC Pharma engages in various further actions and applies two further systems:
More information: www.securpharm.de
For questions related to quality assurance, please do not hesitate to contact us.
