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Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

SOP On Temperature Monitoring of Microbiology Equipments

SOP On Temperature Monitoring of Microbiology Equipments Objective To lay down the procedure for Temperature Monitoring of Microbiology Equipments. Scope This SOP is applicable for Temperature Monitoring of Microbiology Equipments like incubators and refrigerator in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of …

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Total Viable Spore Count Test for Biological Indicators

Total Viable Spore Count Test for Biological IndicatorsObjective To lay down the procedure for Total Viable Spore Count and Resistance Performance test for Biological Indicators  Scope This SOP is applicable for Total Viable Spore Count and Resistance Performance test for Biological Indicators of (Pharmaceutical Company Name). Responsibility Chemist or above …

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SOP on Preparation and Preservation of Culture Suspension

Objective To lay down the procedure for Preparation and Preservation of 10-100 CFU’s/0.l ml Culture Suspension. Scope This SOP is applicable for Preparation and Preservation of 10-100 CFU’s /0.1 ml Culture Suspension in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of SOP. Head …

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SOP on Media growth Promotion, Inhibition and Sterility Check

SOP on Media growth Promotion, Inhibition and Sterility Check Objective To lay down the procedure for Media Growth Promotion, Inhibition and Sterility Check. Scope This SOP is applicable for Media Growth Promotion, Inhibition and Sterility Check in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Chemist or above of QC laboratory. …

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SOP on Maintenance and usage of Reference cultures

Objective SOP on Maintenance and usage of Reference cultures.  Scope This SOP is applicable for Maintenance and usage of Reference cultures. Of (Pharmaceutical Company Name). Responsibility Chemist or above of QC laboratory. Head – Microbiology Section. Accountability Head – Quality Control. Abbreviations and Definitions SOP                             : Standard operating procedure No.                              …

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SOP on Viable Particulate Monitoring – Sterility Testing Area – Microbiology

Objective To lay down the procedure for Viable Particulate Monitoring – Sterility Testing Area – Microbiology. Scope This SOP is applicable for Viable Particulate Monitoring in Sterility Testing Area of Microbiology lab of (Pharmaceutical Company Name). Responsibility Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability Head – …

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SOP on Viable Particulate Monitoring – MLT Testing and Other Areas – Microbiology

Objective To lay down the procedure for Viable Particulate Monitoring – MLT Testing and Other Areas – Microbiology. Scope This SOP is applicable for Viable Particulate Monitoring in MLT Testing and Other Areas of Microbiology lab (Pharmaceutical Company Name). Responsibility Chemist or above of Microbiology Laboratory. Head – Microbiology Section. …

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SOP on Operation, cleaning and maintenance of Sterile Garment Cabinet

Objective To lay down the procedure for the routine operation, cleaning and maintenance of the Sterile Garment Cabinet (SGC).  Scope This SOP is applicable operation cleaning and maintenance of the Sterile Garment Cabinet present in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Chemist or above of QC laboratory. Head – …

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SOP on Operation, Calibration, Cleaning and Maintenance of LAF

Objective To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of LAF. Scope This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of LAF in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of SOP. Head – Microbiology section / Nominee: …

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SOP on Gram Staining

Objective To lay down the procedure for Gram Staining. Scope This SOP is applicable for Gram Staining in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of SOP. Head – Microbiology section / Nominee: Checking of the SOP. Accountability Head – Quality Control / …

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