WHITEPAPER – Minimizing API Supply Chain Risks
By the time your API is brought to a contract manufacturing organization (CMO), you have already put extensive amounts of resources into developing it. It becomes essential that you optimize your API supply chain to be aware of potential risks and minimize the impact of those risks. It can be tempting for some organizations looking to bring drugs to market to manage the entire supply chain themselves; however, this can be risky if you don’t have the experience or resources to go it alone. Partnering with an Active Pharmaceutical Ingredient (API) CMO can help you navigate challenges you may encounter, ensuring you are using best quality practices and minimizing delays in getting medicines to market that use those APIs. By evaluating quality, creating a true partnership, and evaluating the actual cost, you can minimize your supply chain risks.
Importance of a Global Quality System
A top consideration for an API CMO partner is a well-designed global quality system. Ensuring quality practices are designed to meet both customer and regulatory requirements set the foundation for a successful program that is on time and within budget.Global knowledge – A contract manufacturer with a fully integrated global quality system will have current knowledge of global regulatory requirements and follow standardized global quality system procedures to increase process consistency across all sites. The CMO should also have a process for evaluating and efficiently implementing global changes as they occur. Reliability – Quality system history is a good indication of reliability. Look for certification of Current Good Manufacturing Practice (CGMP), which are maintained at each site. Ask if they have had FDA audits or if they are open to an audit where you can validate that they have control of their quality system. Ask to see the Drug Master File (DMF) for your API.Clearly defined quality system components – An effective quality system will have clearly defined components. These include management responsibilities, risk management documentation, change management, corrective and preventative action (CAPA), process performance, and process quality. The system should be designed for the variances in a range of scales, external suppliers, and products being manufactured by the CMO while maintaining consistency.
Developing a Partnership
Selecting a partner that meets your needs requires due diligence as it is one of the most significant decisions you will make before your drug reaches the market. You want a partner that will treat your molecule as its own. A reliable CMO with state-of-the-art capabilities and advanced scientific expertise is critical, particularly if you have a complex chemistry.
Partnering with an API CMO with a favorable reputation and established industry connections can be of great value as they have likely experienced many pitfalls and have access to resources you would not have on your own. The CMO should have a proven track record for a seamless technology transfer and successful validation.
Minimizing Supply Chain Risks Through Proper Cost Evaluation
Thinking only the price associated with short-term needs can be costly in the long run. By focusing on the long-term relationship, including the CMO’s strengths and weaknesses, you will minimize your API supply chain risks.
What does the CMO do to ensure you won’t have an interruption in your supply chain? How easily can they scale? Do they have capacity? Do they have the flexibility to fulfill orders through project phases that might move quickly? How efficient are their manufacturing processes? Delivery delays can be costly. What is the cost to you if you can’t get your API to market because your CMO doesn’t deliver? When evaluating costs, it is essential to look at all aspects that can impact your total costs and supply chain.
AbbVie Minimizes Supply Chain Risks
AbbVie Contract Manufacturing offers world-class custom API services based on more than 70 years of manufacturing excellence. As an embedded CMO with a global network, we offer a broad range of technical capabilities and experience in complex chemistries. We bring the same degree of expertise and passion to your project as we do with our own. To learn more about how AbbVie CMO can minimize your supply chain risks, contact us at 1-847-457-0727 or visit our website at abbviecontractmfg.com.
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