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2017 31 January 2024]

Main Citation "Establishment of appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records (21 CFR 211.68(b))." 2 Detailed Analysis of the Violation Component Identity and Impurity Testing: The firm "failed to adequately test batches of drug products for the identity and strength of active ingredients".2 In modern pharmaceutical analysis, identity and strength testing are performed using automated instruments such as Gas Chromatography (GC) or High-Performance Liquid Chromatography (HPLC)