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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
Investigations in the pharmaceutical industry are critical for identifying and addressing issues that may affect the safety and quality of products, as well as compliance with regulatory standards. A well-conducted investigation can help to determine the root cause of a problem and implement corrective and preventive actions (CAPAs) to prevent it from happening again. Here … Read more