Regulatory Roundup: EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification
EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification.
EMA’s Committee for Medicinal Products for Human Use has issued a concept paper for public consultation on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities. The paper is based on the current “lack of clarity in the existing GMP guide with respect to when a medicinal product should be manufactured in dedicated facilities.” The paper includes a proposal to revise certain sections of the GMP guide (3.6, 5.18, and 5.19), including the incorporation of quality risk management principles as described in the ICH Q9 guideline. The consultation period will close in January 2012 and a revised draft is expected in May 2012. Following that, a draft and final guidance will be issued by the first half of 2013, with a 6-month implementation deadline for industry.
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.
