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Tag: Phase-I

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

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Analyst Qualification Antibiotic Potency Testing Audit Preparation Audit Trail CAPA Cleaning Validation Data Integrity EU Audit Requirements EU Reference GOOD CLINICAL PRACTICE HPLC Calibration ICH Guideline ICH Q10 Interview Questions Investigation laboratory guideline Manufacturing Site MHRA Microbiology 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 Regulatory Affairs Interview SOP SOP for Qualification of Quality Control analyst Stability Study Sterile Pharmaceutical products Sterility Testing USFDA

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