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Tag: Audit Preparation

Most Important Definitions In Clinical Trials.

October 4, 2018 Admin 19 Comments

Most Important Definitions In Clinical Trials. As Per ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE – E6(R1)   What is Clinical Trials? What…

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Posted in: Uncategorized Filed under: Audit Preparation, Clinical Trial/Study, E6(R1), GOOD CLINICAL PRACTICE, ICH Guideline

What is Minimum Requirements of EU Agencies from Production section of Manufacturing site.?

September 18, 2018 Admin 32 Comments

Minimum Requirements in  Production section  for EU authorized Human Pharmaceutical products manufacturing site as per Eudralex Volume 4  part 1 Chapter 5: Production. …

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Posted in: Uncategorized Filed under: Audit Preparation, EU Audit Requirements, Manufacturing Site, Pharmaceutical Production, production

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Tags

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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