Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Water

USFDA: High Purity Water System; Guide To Inspections Of High Purity Water Systems USFDA Inspection

Guidelines Testing

Testing guideline 1 Guideline for testing 2

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Posted by test mar 14

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Test new guideline

Refer discussions under Questions and Answers on Current Good Manufacturing Practice Regulations | Production and

Water system

USFDA: High Purity Water System; Guide To Inspections Of High Purity Water Systems ISPE: Baseline

Stratified Sampling – Content Unif

Refer discussions under Questions and Answers on Current Good Manufacturing Practice Regulations | Production and

Stability & Hold time studies

ICH Q1A (R2): Stability Testing: Stability testing of new drug substances and drug products ICH