Transcription of Data Integrity 483’s / Warning Letters
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Data Integrity 483’s / Warning Letters
483 s / Warning Letters related to QC Data Integrity vis-a-vis Regulatory Expectations Ranjit BarshikarQuality by Design / cGMP Metrics .. US QC / Mfg. relatedLagging metrics: Batch Failure Rate Right First Time Out of Specification (OOS) / Laboratory Failure Investigation RatesLeading metrics: Quality System Effectiveness Process Capability Quality Culture Index Quality Culture IndexUS FDA Surprise Inspections .. Until now, FDA s inspections of Indian pharma plants have always been with prior notice. The surprise checks and aggressive surveillance are being considered because of instances of fabrication of documents and human errors . India s growing importance as a hub of Generic producers and rising compliance problems prompt regulator to consider the plan FDA expanded its inspection team in India from 12 to FDA Increasing Inspections.
US FDA Surprise Inspections … •Until now, FDA’s inspections of Indian pharma plants have always been with prior notice. •The surprise checks and aggressive surveillance are being considered because of “instances of fabrication of documents and human errors”. •India’s growing importance as a hub of Generic producers and rising
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