Methodologies for transfer of an analytical method

ISBN-13: 9783846514719 / Angielski / Miękka / 2012 / 84 str.

Vidhi M. Desai; Rajesh K. Patel; Bhuvan P. Raval

Opis

An analytical method transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion at two or more different sites or laboratories and meets all acceptance criteria. This process is driven by compliance and governed by a statistical treatment of the resulting data. McGonigle defined Method transfer as "the introduction of a validated method into a designated laboratory so that it can be used in the same capacity for which it was originally developed". The transfer of a method from a laboratory to a production site is an important step in the development cycle of new pharmaceutical products.

O autorze

Vidhi M. Desai, M. Pharm, has completed her M. Pharm in Quality Assurance at S K Patel College of Pharma. Edu. & Res., Ganpat Vidyanagr. Rajesh K. Patel, M.Pharm (Ph.D.) is an Asst. Professor at K J College of Pharmacy, Vadasma. Bhuvan P. Raval, M.Pharm, PGDPRA, MBA, FSAB, (Ph. D.) is an Asst. Professor at K J College of Pharmacy, Vadasma.