Regulatory Roundup: USP Releases Proposed Supply Chain Guidelines
USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.
The US Pharmacopeia has released proposed guidelines on ensuring the integrity of the pharmaceutical supply chain. The guidelines cover five main areas: good importation practices, counterfeit drugs and medical devices, best practices to combat counterfeit drug and medical devices, diversion and theft, and natural disasters. The guideline is open for public comment through May 31, 2012, and will appear in the Pharmacopeial Forum 38(2). A May 2012 USP workshop will address the comments received and the draft chapter.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
