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Tag: USFDA

GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS

September 30, 2020 Admin Leave a comment

GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS Note: This document is reference material for investigators and other FDA personnel.…

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Posted in: Microbiology Filed under: Microbiology, USFDA, Water System

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II)

October 1, 2018 Admin 7 Comments

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :-  The all…

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Posted in: Uncategorized Filed under: Investigation, OOS, Out of Specification, Phase-I, Phase-II, USFDA

How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

Admin 28 Comments

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results…

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Posted in: Uncategorized Filed under: Microbiology, Out of Specification, Out of Trend, Phase-I, Quality Control, USFDA

What is Data Integrity In Pharmaceutical Industry…???

September 29, 2018 Admin 2 Comments

What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line…

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Posted in: Uncategorized Filed under: Audit Trail, Data Integrity, EU Audit Requirements, MHRA, Quality Control, USFDA

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