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 (MDD) (Formerly known as the Micro OOS Task Force)
•Tangentially addressed in FDA Aseptic Processing Guidance albeit it is focused on sterile products. http://www.fda.gov/cber/gdlns/steraseptic.pdf