TY - JOUR T1 - Considerations on Auditing and GxP Requirements along the Product Lifecycle JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 396 LP - 402 DO - 10.5731/pdajpst.2012.00881 VL - 66 IS - 5 AU - Stephan Rönninger AU - Siegfried Schmitt AU - Vijaya Rangavajhula AU - Emily Hough AU - Jim Lyda Y1 - 2012/09/01 UR - http://journal.pda.org/content/66/5/396.abstract N2 - The purpose of this article is to summarize the current GxP standards which need to be applied by global pharmaceutical manufacturers in order to achieve compliance with global regulatory requirements. Companies need to follow and audit against relevant global/regional and domestic laws as well as focusing on the lifecycle aspects of the product and processes involved from development through to routine commercial manufacture. This article was written under the auspices of PDA's Paradigm Change for Manufacturing Operations (PCMOSM) task force on risk-based auditing. ER -