HPLC for Pharmaceutical Scientists (Kazakevich/HPLC for Pharmaceutical Scientists) || The Role of HPLC in Technical Transfer and Manufacturing

✍ Scribed by Kazakevich, Yuri; LoBrutto, Rosario

• Publisher: John Wiley & Sons, Inc.
• Year: 2006
• Tongue: English
• Weight: 436 KB
• Edition: 1
• Category: Article
• ISBN: 0471681628
• DOI: 10.1002/9780470087954.ch16

✦ Synopsis

Analytical technology transfer and manufacturing is the mechanism by which knowledge acquired about a process for making a pharmaceutical active ingredient or dosage form during the clinical development phase is transferred from research and development to commercial scale-up operation or shared between internal groups or with third parties. Analytical technology transfer guarantees that laboratories can routinely execute tests, obtain acceptable results, and be able to accurately and independently judge the quality of commercial batches. One of the most important analytical technology transfers is high-performance liquid chromatography (HPLC) methods. The success or failure of analytical technology transfers are judged on the merits of data generated using HPLC. Consequently, a major focus of regulatory authorities [1-3] is on methods transfer as a critical link in the drug development continuum. Depending on the structure of the pharmaceutical organization, transfer of analytical technology and manufacturing may occur at the end of the phase II clinical studies or during the transition from phase II to phase III. However, for a successful transfer of analytical technology to occur, the existence of HPLC methods that have been fully validated in accordance with the ICH guidelines on validation will be required [6]. A full description of method validation is provided in Chapter 9.