Codema Pharma

Codema Pharma, established in 2009, is an independent rating company dedicated to enhancing evaluation standards within the pharmaceutical industry. The company specializes in developing protocols that provide qualitative and compliance information concerning critical components of the global pharmaceutical supply chain. By standardizing evaluation criteria, Codema Pharma serves as a pivotal link between pharmaceutical suppliers and buyers, facilitating the qualification process and ensuring adherence to high industrial standards. The evaluation system developed by Codema Pharma encompasses a range of protocols with specific scopes, addressing areas such as Good Manufacturing Practices (GMPs), quality and compliance, regulatory additional testing and requirements, integrity, plant and equipment standards, environmental health and safety (EHS), and N-Nitrosamines risk assessments. These protocols are continually revised to align with the latest industry developments, ensuring their relevance and effectiveness. Operating under established Rules of Procedures, Codema Pharma guarantees neutrality and independence akin to those of a certification body. Codema Pharma collaborates with sector bodies and institutions, enabling the company to dynamically address the evolving needs of pharmaceutical companies by developing new protocols or revising existing ones. As a partner member of the European Federation of Generic and Biosimilar Medicines (Medicines for Europe), Codema Pharma actively contributes to defining harmonized criteria for evaluating pharmaceutical supply chains. The company acknowledges independent pharmaceutical professionals, known as Codema Acknowledged Experts (CAEs), who are consultants specializing in pharmaceutical substances, starting material production, GMP, regulatory issues, and related fields. These experts, whether freelancers or affiliated with larger companies, maintain professional responsibility and have no commercial ties with Codema Pharma. To become a CAE, professionals must meet specific criteria, including recognition or accreditation by local or international pharmaceutical bodies, prior experience in conducting audits or similar activities for EU or US pharmaceutical buyers, and publication of technical or scientific articles in reputable reviews. A special written endorsement from a recognized body or organization may substitute one of these criteria. Codema Pharma maintains records of communications regarding the professional activities of each CAE within the rating process framework, ensuring transparency and accountability. Codema Pharma's Rating Program evaluation system operates according to specific standard procedures. Interested parties can access and download relevant documents, including the Rules of Procedures, Rating Program Application, Evaluation Protocols, and CAE Application (for auditors), by providing their name, surname, and email address. In response to the European Medicines Agency's directive on the risk assessment of N-Nitrosamine impurities, Codema Pharma has developed protocols (RP890 and RP891) to assist Marketing Authorization Holders (MAHs) and their suppliers in conducting thorough evaluations of risk factors for N-Nitrosamines formation in drug products and their components. These protocols are based on ICH M7 and ICH Q9 principles and are accessible free of charge to support the industry in meeting regulatory requirements. Codema Pharma is headquartered at Clos Chapelle-aux-Champs, 30, B-1200 Brussels, Belgium. For inquiries, the company can be contacted via telephone at +32 2 880 62 24, fax at +32 2 880 62 01, or email at [email protected] .