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Tag: Microbiology Techniques

Antimicrobial Effectiveness Testing (USFDA)

October 20, 2020 Admin Leave a comment

Antimicrobial Effectiveness testing is described in USP <51>.  Previously this chapter was known as “Preservative Effectiveness Testing”. Detailed procedure for…

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Posted in: Microbiology Filed under: Antimicrobial Effectiveness testing, Microbial Testing, Microbiology, Microbiology Techniques

SOP For Microbial Culture Management

September 25, 2020 Admin Leave a comment

A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed…

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Posted in: Microbiology, SOP Filed under: Microbial Culture Management8, Microbiology, Microbiology SOP, Microbiology Techniques

SOP for Media Fill Validation

September 10, 2020 Admin Leave a comment

Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility.  A “media fill” (sometimes known as a “process simulation”)…

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Posted in: Microbiology Filed under: Media Fill, Media Fill Validation, Microbiology Techniques

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Analyst Qualification Antibiotic Potency Testing Audit Preparation CAPA Change Management System Cleaning Validation Compression Machine Data Integrity EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 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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