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. Recruiting about 100+ inspectors in India. Move towards surprise inspections. About 3 B $ budget approved as per Dr.
Quality Metrics…..QC / Mfg. related Lagging metrics: •Batch Failure Rate •Right First Time •Out of Specification (OOS) / Laboratory Failure Investigation Rates
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