Avoid Delays with Good Clinical Manufacturing Practice
In a complex surrounding, many aspects of a trial can determine its outcome. One of which is clinical manufacturing. This pivotal element in the supply chain can create numerous problems if not properly managed. The rising number of regulations has meant processes involved have followed suit. Thus, extensive attention is required to ensure complications are resolved or avoided.
Fail to prepare, prepare to fail…
This common term has been around for quite some time, and it also applies to the world of clinical manufacturing. Starting the planning process early candiminish potential challenges, such as delivery issues. Establishing a timeline with all the teams involved means provisional deadlines can be set for all processes. As a result, precautions can be put in place to allow any potential overruns to occur.
Another common difficulty in clinical manufacturing is regulatory compliance. Misunderstanding and/or misinterpretation are the most common of all, which can delay the entire process. To minimize such risk, extensive knowledge of the regulations are required, thus working with a local regulatory expert can minimise the chance of this happening.
In a world of constant change, change is the only constant. The conventional mission to create a blockbuster drug is no longer the norm. Many new products are more complex technically, and are produced in smaller volumes. This changing business environment has altered the clinical manufacturing business, and the industry must adapt.
To maintain competitiveness, flexibility is essential. Single-use manufacturing equipment has seen a rise in usage in comparison to traditional steel tanks. The former can be installed quickly, meaning it can adapt to demand when called up on. Furthermore, the time taken to transition between products will also be reduced, as less cleaning is required. Consequently, new projects can commence near instantly.
Don’t miss the chance to discuss this pressing topic with clinical leaders in Chicago! Join us in September as we delve into various aspects of clinical supply! For more information, please visit: http://www.arena-international.com/ctsmidwest?clearcache=1 or alternatively email us at: firstname.lastname@example.org
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