Regulatory and Guidance Documents •2006 FDA Guidance for Industry – Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production. •ICH Q6A •ICH Q7A •USP 31 <1117> Best Microbiological Practice •Addressed in PMF Newsletter (Sutton and Settineri) http://www.microbiologyforum.org/PMFNews/PMFNews.12.11.0611.pdf (Sutton) http://www.microbiologyforum.org/PMFNews/PMFNews.13.06.0706.pdf (Settineri) •Addressed in PDA Draft Technical Report Points to Consider When Investigating Microbiological Data Deviations Read more about What are the guidance documents that govern MDDs?(Microbial Data Deviation Investigations)[…]