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Tag: Phase-II

Out of Specification Investigation Phase II & III (MHRA)

July 1, 2019 Admin 2 Comments

Out of Specification Investigation Phase II (Unknown Cause / No Assignable  Cause ) & Phase III Phase II Investigation  –…

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Posted in: Quality Control Filed under: MHRA, Out of Specification, Phase - III, Phase-II

Out Of Specification Investigation Phase II (MHRA)

June 26, 2019 Admin Leave a comment

Out Of Specification Investigation Phase II (MHRA) Conducted when the phase I investigations did not  reveal an assignable laboratory error. …

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Posted in: Quality Control Filed under: Out of Specification, Phase Ia, Phase Ib, Phase-II, Quality Control

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

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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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