RT Journal Article SR Electronic 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 FD Parenteral Drug Association (PDA) SP 396 OP 402 DO 10.5731/pdajpst.2012.00881 VO 66 IS 5 A1 Rönninger, Stephan A1 Schmitt, Siegfried A1 Rangavajhula, Vijaya A1 Hough, Emily A1 Lyda, Jim YR 2012 UL http://journal.pda.org/content/66/5/396.abstract 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.