OOS/OOT Guideline- MHRA
Out of Specification (OOS) and Out of Trend (OOT) guideline was published by MHRA (Medicines and Healthcare Products Regulatory Agency in October 2017 which is complementary to FDA guidance on investigating OOS Test results in Pharmaceutical Production October 2006. Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be … Read more