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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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Analyst Qualification Antibiotic Potency Testing Audit Preparation CAPA Change Management System Cleaning Validation Compression Machine Data Integrity EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 laboratory guideline Manufacturing Site MHRA Microbial Testing Microbiology Microbiology SOP Microbiology Techniques OOS Out of Specification Out of Trend Pharmaceutical Production Pharmaceutical Quality System Phase-I Phase-II Phase Ia Phase Ib production Production SOP QMS Qualifications Protocol Qualification  Steps Quality Assurance Quality Control Quality Control Laboratory Quality Control SOP Quality Management System SOP SOP for Qualification of Quality Control analyst Stability Study Sterile Pharmaceutical products Sterility Testing USFDA
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