Considerations on Auditing and GxP Requirements along the Product Lifecycle

PDA J Pharm Sci Technol. 2012 Sep-Oct;66(5):396-402. doi: 10.5731/pdajpst.2012.00881.


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 (PCMO(SM)) task force on risk-based auditing.