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Exclusive Life Science Feature it has fixed a problem and doesn't need to share it. Analytical data may also be something your CMO resists sharing for proprietary or technology-transfer reasons. To some extent, new Web-based systems like SharePoint help overcome com- munication blocks between CMOs and their clients. Both parties can post and share documents on a secure website, conquering time-zone differences and other displacements between multiple locations spread around the world. The ultimate technological solution may start on the shop floor, however. The FDA supports universal adoption Your To-Do List The following is a checklist of the basic steps you — your company and management — should take when a CMO you depend on receives an FDA Form 483 or warning letter. FORM 483s 1) Make sure you are fully informed and involved in coordinating with your CMO in the response to any 483. For fixing major problems, draw up an action plan together. 2) If the FDA inspector notes only a few minor errors, the CMO may fix them immediately and report the changes, but should still inform you. 3) If the errors are more serious or numerous for immediate repair, the 483 recipient should respond with a letter to the FDA outlining the action plan for fixing them. UPM's Flexibility. Your Success. UPM Pharmaceuticals has the flexibility to consistently meet your solid dose needs. We are a partner committed to optimizing your process and combining expertise to ensure you meet strategic and time-sensitive goals. formulation development clinical materials supply analytical services commercial manufacturing complex formulations To learn more, visit www.upm-inc.com or call +1 410 843 3738. 4) If you don't already have a backup supplier, move quickly to obtain one; you may have some lead time should more serious problems develop. 5) If lacking, set up ongoing communications between your company and the CMO team responsible for your product, involving frequent assessment meetings and daily postings on a secure Web-based system such as SharePoint. 6) Trust but verify. Invest in independent auditing of CMO facilities to ensure production quality and compliance. WARNING LETTERS 1) Realize that warning letters arrive only when 483s are ignored — or when they fail to identify deeper problems. If you haven't read the signs already, get with your CMO and go into full alert. 2) As with 483s, coordinate with the CMO to develop an action plan. 3) Request another FDA inspection after the problems are fixed. 4) If the CMO cannot afford or is unwilling to fix the problems, weigh the cost of underwriting the repairs versus potential lost sales or the costs of obtaining additional supply. 5) If you already have a second supplier, prepare to shift as much production as needed and as possible to it. 6) Prepare communications and, if necessary because of supply shutdown, a rationing program for affected patients and others such as physicians and payers. You, the sponsor, must put a high priority on manufac- turing quality and be involved with your CMO's efforts to maintain and improve it! 22 The CMO Leadership Awards 2012