PT - JOURNAL ARTICLE AU - Rönninger, Stephan AU - Schmitt, Siegfried AU - Rangavajhula, Vijaya AU - Hough, Emily AU - Lyda, Jim TI - Considerations on Auditing and GxP Requirements along the Product Lifecycle AID - 10.5731/pdajpst.2012.00881 DP - 2012 Sep 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 396--402 VI - 66 IP - 5 4099 - http://journal.pda.org/content/66/5/396.short 4100 - http://journal.pda.org/content/66/5/396.full SO - PDA J Pharm Sci Technol2012 Sep 01; 66 AB - 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.