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Tag: Microbial Testing

Sterility Testing in Pharmaceutical Product as per USFDA Guideline

October 20, 2020 Admin Leave a comment

Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility…

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Posted in: Microbiology Filed under: Microbial Testing, Microbiology, Pharmaceutical Product, Sterility Testing, USFDA Guideline

Antimicrobial Effectiveness Testing (USFDA)

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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 on Microbial Testing of Drain Water

March 26, 2020 Admin Leave a comment

The Purpose of this SOP is To lay down the procedure for Microbial testing of drain water in the production…

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Posted in: Microbiology Filed under: Drain Water, Microbial Testing, Microbiology, SOP

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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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