Regulatory Compliance

Understanding ICH Q2 – The Cornerstone of Analytical Validation

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The world of pharmaceuticals is built on precision, reliability, and trust. At the heart of ensuring that medicines meet stringent quality standards lies ICH Q2, a globally recognized guideline that governs the validation of analytical procedures. For anyone involved in pharmaceutical development, quality control, or regulatory affairs, ICH Q2 is more than just a technical … Read more

OOS/OOT Guideline- MHRA

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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