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Tag: Out of Trend

Out of Specification &Out of Trend Investigations (MHRA)

June 25, 2019 Admin 2 Comments

Out of Specification &Out of Trend Investigations (MHRA) Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend…

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Posted in: Quality Control Filed under: MHRA, OOS, OOT, Out of Specification, Out of Trend, Quality Control

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

October 1, 2018 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 Audit Preparation Calibration CAPA Change Management System Cleaning Validation Compression Machine Computerized System EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 laboratory guideline MHRA Microbial Testing Microbiology Microbiology SOP Microbiology Techniques OOS Operation 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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