ICH Pharma Quality Guideline ICH Guideline Link 1. ICH GUIDELINE INDEX I. Q1A – Q1F STABILITY Q1A (R2) Stability Testing of New Drug Substances and Products Q1B Stability Testing: Photostability Testing of New Drug Substances and Products Q1C Stability Testing for New Dosage Forms Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug…
SOP of Operation and backwash of Multigrade filter Objective To lay down the procedure for operation and backwash of Multigrade filter. Scope This SOP is applicable for operation and backwash of Multigrade filter.to formulation plant of Pharmaceutical Company. Responsibility Technician/above –Eng. is responsible for operation and backwash of Multi grade filter. Accountability Department Head &…
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SOP on Media Preparation Objective: To lay down the procedure for Preparation of Media. Scope: This SOP is applicable for preparation of sterile media used in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility: Microbiologist or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control Head – Quality Assurance. Abbreviations and Definitions…
SOP on operation, cleaning and maintenance of the Steri-check system Objective: To lay down a procedure for operation, cleaning and maintenance of the Steri-check system. Scope: This SOP is applicable to Steri-check system present in the microbiology lab of (Pharmaceutical Company Name). Responsibility: Officer or above of Microbiology Laboratory: Head – Microbiology section / Nominee….
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SOP of Hot Air Oven Objective To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven. Scope This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Officer or above of Microbiology Laboratory. Head – Microbiology section. Accountability…
SOP of Vortex mixer Objective To lay down the procedure for Operation and Cleaning of Vortex mixer Scope This SOP is applicable for Operation and Cleaning of Vortex mixer in Microbiology Laboratory. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head – Quality Control. / Nominee….
SOP of Media Decontamination and Disposal after used Objective To lay down the procedure for Decontamination and Disposal of Used Media Scope This SOP is applicable for Decontamination and Disposal of Used Media. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head – Quality Control. /…
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SOP of LAL Reagent Objective To lay down the procedure Confirmation of Labeled LAL Reagent Sensitivity. Scope This SOP is applicable for Confirmation of Labeled LAL Reagent Sensitivity tested in Microbiology Laboratory. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head – Quality Control I Nominee….
SOP On Temperature Monitoring of Microbiology Equipment’s Objective To lay down the procedure for Temperature Monitoring of Microbiology Equipment’s. Scope This SOP is applicable for Temperature Monitoring of Microbiology Equipment’s like incubators and refrigerator in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of SOP. Head – Microbiology section /…
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SOP of Total Viable Spore Count Test for Biological Indicators Objective 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 of QC…
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SOP of Culture Suspension Preparation and Preservation 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…
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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 Checks in the Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Chemist or above of QC laboratory. Head – Microbiology Section….
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SOP of Reference cultures Maintenance and usage 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…
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SOP on Viable Particulate Monitoring – Sterility Testing 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….
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ASEPTIC ENVIRONMENT: NONVIABLE VS VIABLE MONITORING Any contamination poses a risk to the contents of the cleanroom and, in some industries, is a threat to the end-user or product. What Is An Aseptic Environment? Aseptic is defined as being “free from contamination caused by harmful bacteria, viruses, or other microorganisms. Cleanrooms are carefully maintained and…
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SOP 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 – Microbiology…
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SOP of LAF Operation, Calibration, Cleaning, and Maintenance 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…
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SOP of Gram Staining Objective: To lay down the procedure for Gram Staining 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 / Nominee: Compliance of…
SOP of Dry Bath Incubator Objective: To lay down a procedure for operation, calibration, cleaning and maintenance of Dry bath incubator Scope This SOP is applicable for operation, calibration, cleaning and maintenance of dry bath incubator in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section /…
SOP on Spore Staining Objective: This SOP is applicable for spore staining in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above Microbiology laboratory: Preparation of the SOP. Head – Microbiology section/ Nominee: Checking of the SOP. Accountability Head – Quality Control/ Nominee: Compliance of SOPs. Abbreviations and Definitions SOP : Standard operating procedure…
