Solid solutions for contract manufacturing
A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand their technical resources, without increased overheads.
Contract manufacturing is a form of outsourcing where a manufacturer enters a formal agreement with another manufacturing firm for its parts, products, or components. The biggest factor driving the growth of CMOs in the pharmaceutical industry is the growing need for state-of-the-art processes and production technologies, which have proven highly effective in meeting regulatory requirements.
FDA and the risk-based schedule
Inspection readiness for CDMOs
As a CDMO, it is important to be aware of FDA inspections and the new risk-based schedule that the organization has adopted. In order for drugs to be approved quickly and to help conserve resources, the FDA switched to a risk-based inspection schedule. Accordingly, higher-risk CDMOs, such as those producing more complex drugs or drugs with the potential for greater risk to consumers, are subject to more frequent inspections. It is essential for CDMOs to understand the new requirements and ensure their processes, facilities, and controls are adequate to meet the FDA's requirements for approval. By understanding the FDA's regulations and risk-based inspection schedule, a CDMO can ensure that the drugs it produces are safe and effective for consumers.
At biomedion, we understand that contract development and manufacturing organizations (CDMOs) are faced with the challenge of product development, manufacture of active pharmaceutical ingredients (API), and manufacture of finished dosage forms (FDF). All of these processes need to be carried out from small-scale clinical batches to large-scale commercial production, making technical transfer to a CDMO a critical task. It is not surprising that data transfer and archiving is often difficult, time consuming and costly.
To minimize these challenges, it is important to have a technical team in place from the initial stages of development through to commercialization. At biomedion, we have the experience and expertise needed to ensure a successful technical transfer and to help our CDMO partners achieve their goals.
We understand that raw-data challenges can hinder the archiving process and we offer a range of data archiving solutions to help our CDMO partners manage this. Our tailored solutions include secure data storage and secure backup, meaning you can have peace of mind that all your data is safe and secure. At biomedion, we are committed to helping our CDMO partners succeed and we understand that successful technical transfer is an essential part of this.
Our experts are on hand to provide the highest level of support, ensuring the process is stress-free and the highest quality standards are met. For more information about our technical transfer and data archiving services for CDMOs, please contact us today. Our team of professionals are ready to help you achieve your goals.
CDMOs have an important role to play in the development of essential drugs, and in light of the FDA's limited resources and the demand for new and innovative drugs, the agency has introduced a risk-based schedule for inspections.
For CDMOs, this means that those processing and manufacturing more complex drugs, or those with the potential for greater risk to consumers, are more likely to be inspected than those producing low-risk drugs. At biomedion, we understand the importance of adhering to the FDA's new risk-based inspection schedule.
It is essential for CDMOs to be compliant with the FDA's quality standards in order to ensure the safety of the drugs they are creating. That is why they strive to remain up-to-date with the latest information and regulations pertaining to the FDA's risk-based inspection schedule.
We understand that the FDA requires CDMOs to provide thorough documentation that accurately reflects the methods, facilities, and controls used for the manufacture, processing, and testing of the drug. In addition, CDMOs must address any data challenges associated with archiving the documentation.
This can be a daunting task, and biomedion is here to help. We are experts in data management and can assist you in meeting the FDA's quality standards. At biomedion, we understand the importance of FDA compliance and the need to remain up-to-date with the latest information and regulations. We are committed to making the process of meeting the FDA's requirements as seamless and stress-free as possible, so you can focus on what is most important—developing essential drugs that help save lives.
At biomedion, our mission is to provide our customers with the most innovative solutions to help them succeed in their operations. With our suite of digital solutions, customers can rest assured that their operations are safe, secure and compliant with regulatory guidelines. We are committed to helping our customers achieve the highest levels of GxP, efficiency and success.
"Medicine is a science of uncertainty and an art of probability"
William Osler | Founcer of the Johns Hopkins Hospital
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