Whitepaper: ABCs of reference standard management
Reference standards play a critical role in pharmaceutical drug development from preclinical to commercial analytical support.
Bio-analytical methods often require internal, metabolite and active ingredient standards in support of method validation and cGLP testing. Standards that support cGMP testing, such as API impurities, are introduced during clinical trial manufacturing of drug substance and drug product. The management of Certificate of Analysis (CoAs), inventory and supplies to external users, is critical to avoiding delays in drug development.
Here we profile reference standard management and discuss types of standards, standard via synthesis, officially sourced standard, suppliers, characterisation, and impurity testing. In addition, we will discuss standards storage, retesting and sample administration.
The rest of this content is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!
Related content from this organisation
- Whitepaper: ABCs of reference standard management
- Recent BPT acquisitions
- Whitepaper: Ten things you should know before contracting a custom synthesis project
- Whitepaper: The impacts of Brexit on the bio/pharmaceutical industry
- Eurofins: The largest scope of global services. The sharpest focus on data integrity.