Quality
Continuous monitoring and improvement of processes
Quality
Continuous monitoring and improvement of processes
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 is synonymous with a reliable quality assurance system that goes far beyond what is required by law. At CC Pharma, this begins long before we even receive the pharmaceuticals. As an importer of medicinal products, we have a large network of suppliers that has proven successful over many years. In addition, we are regularly strengthening our technological and personnel resources to enable the seamless and systematic monitoring of the supply chain. All suppliers undergo an extensive qualification process that includes a risk-based audit of the respective supplier. This enables us to see for ourselves the quality of the supplier’s storage facilities and products on site.
As soon as the medicinal products arrive on our premises they undergo an extensive incoming goods inspection. In the process, covert security features and the further internal handling of the products are also checked. Because naturally, our integrated quality management system also includes internal process safety.
Following inspection of the incoming goods all packaging materials are made available and checked. This starts the production process as such, in which a German-language package insert is added and the secondary packaging produced for the German market. The finished medicines are then subjected to a final inspection, and following clearance by a qualified person (QP) are prepared for the shipping department. From there, the products are distributed to pharmacies and pharmaceutical wholesalers. Quality assurance is by means of an integrated control system across the entire process.
Providing and maintaining standard operating procedures (SOPs) and adequate documentation are important elements of internal process safety. We use a risk-based Change Control System to evaluate and manage all process-related changes within the company. In a continuous improvement approach, “CAPAs” (corrective and preventive action) are assigned to each error occurring to improve the process. Moreover, alongside internal process safety, our integrated control system also includes regular external checks of our supplier network.
Our quality management in compliance with GMP and GDP guidelines includes e.g.:
At CC Pharma we do our utmost to always ensure the greatest possible safety of our pharmaceutical products. As well as the official marketing authorization, the implementation of the EU Falsified Medicines Directive is especially crucial. This directive was established to protect patients from falsified medicines in the legitimate supply chain. Every single pack is provided with a tamper-evident seal. In addition, it is printed with an individual 2D barcode so that the medicine can be precisely identified from production to delivery to the pharmacy.
Pharmacies therefore use this code to confirm the authenticity of the medicines. We attach great importance to this, because for us, quality management does not end until a patient has safely received their medicine.
For more information, go to: www.securpharm.de
As one of the leading pharmaceutical importers in Germany, we have a lot of responsibility at CC Pharma. This is why the issue of drug safety is a top priority for us. To ensure the consistently high safety and quality of our medicinal products we don’t leave anything to chance and work with an integrated control system. Only this detail-driven approach allows us to meet our high quality standards.
All CC Pharma products are officially certified based on a precisely defined production and monitoring process. This includes the determination and documentation of binding procedures and work instructions. In addition, we are committed to the systematic upskilling of our employees.
Through regular training sessions, we repeatedly refresh the specialist knowledge of our employees and give them the confidence that they need. However, should any questions arise, they can consult our highly qualified in-house experts at any time. These specialists are on hand to provide support and advice on the basis of their sound professional and technical expertise and longstanding experience.
Before the goods are handed over to shipping, they undergo a systematic final inspection, where every batch produced is precisely checked and documented with photos on the basis of an inspection log. This is a basic prerequisite for the final release of the medicines by the qualified person (QP). And only then have we done everything in our power to ensure the consistently high quality of all medicinal products – and can then hand over the product to our shipping department in good conscience.
