Codema has developed a series of protocols (RP890 and RP891) in response to EMA’s Directive EMA/189634/2019 on the risk assessment of N-Nitrosamine impurities.
Our world-class experts and auditors have designed the protocols in collaboration with European regulators, authorities and industry groups. They are based on ICH M7 and ICH Q9 principles and outline the requirements needed for a thorough evaluation of all risk factors for N-Nitrosamines formation in a drug product and its components.
The deadline set by EMA to complete the risk evaluations is on March 31, 2021. To support MAHs and their suppliers of APIs/excipients and in preparation of the confirmatory testing phase, some of Codema’s protocols are now accessible completely free of charge.
To get your free copy of the protocols marked as “accessible”, please complete the form by entering all the required fields and we will send you the documents.
<<At the beginning process, we were faced with a large number of nitrosamines risk assessments to perform for 60 to 70 different APIs. Thanks to Codema’s risk-based approach and recommendations, we are on track in completing the assessments and defining risk mitigation plans for our drug products. We found Codema’s protocols a powerful and well-detailed tool to gather and evaluate the information required for the assessment. Approaching our suppliers in an organized way, having clear guidelines and priorities saved us a lot of time and facilitated the communication with the suppliers. If more suppliers would adopt Codema’s harmonized approach and be familiar with the protocols, the entire industry would benefit of a prompter deliver of high-quality manufacturing data.>>
Danai Tasopoulou Head QA/ QP at ELPEN
ELPEN is a leading Greek pharmaceutical company specialized in branded generics
Codema Pharma (Codema) is an independent rating company helping pharmaceutical and life science companies evaluate their supply chain and meet the latest industry requirements. The company serves innovators, manufacturers and suppliers of medicinal drugs, active pharmaceutical ingredients, medical devices and cosmetic products.
Since its foundation in 2009, Codema positioned itself as the preferred rating partner and advisor to European regulators and authorities, actively contributing in defining harmonized criteria for the evaluation of pharmaceutical supply chains. This gave Codema a unique insight into regulatory, quality and compliance, based on which, the company developed evaluation systems, processes and protocols.
Codema’s world-class experts and auditors successfully support customers asses complex and critical data, identifying gaps and risks, while optimizing time and resources. Codema strives to improve the dialogue between companies, regulators and suppliers and it is proud to contribute ensuring the highest levels of safety and quality for pharmaceutical products and active ingredients.
Codema is a Partner Member of Medicines for Europe.
To learn more about Codema visit our webpage www.codemapharma.com
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