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Tag: Phase Ib

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

Out Of Specification Investigation Phase Ia & Phase Ib (MHRA)

June 25, 2019 Admin Leave a comment

Out Of Specification Investigation Phase Ia & Phase Ib (MHRA) Phase Ia Investigation Definition: Out of Specification Investigation Phase la…

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

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Analyst Qualification Antibiotic Potency Testing Audit Preparation Audit Trail CAPA Cleaning Validation Data Integrity EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 Investigation 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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