sop for qualification of analyst microbiologist
1.0 OBJECTIVE
1.1 To describe the procedure for qualification of analyst. The purpose of this exercise is to ensure that the analyst is qualified for gowning procedure and sterility and bacterial endotoxin test prior performing the tests on regular basis.
2.0 SCOPE
2.1 This procedure is applicable for all analyst working in production and microbiology department.
3.0 RESPONSIBILITY
3.1 Microbiologist – Quality control microbiology.
4.0 ACCOUNTABILITY
4.1 Head – QC
5.0 PROCEDURE
5.1 Gowning Qualification
5.1.1 For production analyst: Enter into the production sterile area by following the instructions for entry and gowning as per the SOP
5.1.2 For Microbiologist: Enter into the microbiology lab sterile area by following the instructions for entry and gowning as per the SOP
5.1.3 Take the personnel monitoring samples from the different locations (forehead, left & right chest, left & right armpit, left & right forearms, left & right fingers, left & right booties) by contact plate method.
5.1.4 Exit out from the sterile area and bring the contact plates to incubator and incubate as per requirements.
5.1.5 Follow the same activity for three consequent days.
5.1.6 Note down the results of personnel monitoring in report.
5.2 Microbial Limit Test Qualification
5.2.1 Manager QC should select three recently approved batches of the same product.
5.2.2 Analyst should analyze the samples of three batches individually.
5.2.3 Analyst should follow the SOP for microbial limit test.
5.2.4 The results should be compared against the previous results.
5.3 Sterility Test Qualification
5.3.1 Manager QC should select three recently approved batches of the same product.
5.3.2 Analyst should analyze the samples of three batches individually.
5.3.3 Analyst should follow the SOP for sterility test.
5.3.4 The results should be compared against the previous results.
5.4 Bacterial Endotoxin Test Qualification
5.4.1 Manager QC should select three recently approved batches of the same product.
5.4.2 Analyst should analyze the samples of three batches individually.
5.4.3 Analyst should follow the SOP for Bacterial Endotoxin test.
5.4.4 The results should be compared against the previous results.
5.5 FREQUENCY : Every new analyst
6.0 ABBREVIATIONS
QC : Quality Control
QA : Quality Assurance
SOP : Standard Operating Procedure
:
sop for calibration and validation of micro autoclave
sop for Sterility failure investigation
cleaning and operation of discard autoclave
sop for operation of fogger machine
sop for Biological assay of lactic acid bacillus
sop for preparation of culture inoculum
STP for sterility testing of sterile gloves
sop for Operation and calibration of active air sampler
sop for transfer of material for testing and sampling in sterile area
entry & exit procedure in microbiology laboratory
Growth Promotion Test In Microbiology Laboratory
Operation of B.O.D in Microbiology Laboratory
Operation of Horizontal Laminar Air Flow in the microbiology laboratory
Operation and cleaning of Pass Box.
Operation and cleaning of air sampler
Cleaning and Sterilization of Glassware
Analysis of water for microbial load in microbiology lab
Operation and temperature monitoring of Refrigerator
Fumigation of Microbiology Laboratory.
Entry & Exit procedure In Sterility Area
SOP for Microbial analysis of Raw Material Finished Products
SOP for Operation & Calibration of pH meter in Micro Department
SOP for Operation & Calibration of pH meter in Micro Department
SOP Operation and calibration of Hot Air Oven In Microbiology
SOP for operation cleaning & calibration of Digital colony counter
SOP for Operation And Cleaning of Microscope
sop for Media Preparation and Consumption
sop for Receipt Storage and Usage of Culture Media
sop for Cleaning Sanitization And Disinfection In Microbiology
sop for Environmental monitoring of all the Classified area
sop for Handling and Sub culturing of Microbial cultures
sop for Media Growth Promotion Test and various Microbiological test
sop for BOD incubator operation and cleaning
sop sampling of water for microbiological analysis
sop for Disinfectant Efficacy Test
sop for for cleaning and operation of vortex mixture
sop for Temperature & Relative Humidity Monitoring
sop for Operation and Calibration of Heating Block
sop for Sterility Testing of Microbiology
sop for Disposal of Culture Media
sop for Drain point of Microbiology
sop for entry & exit procedure In Microbial limit test and Biosafety
sop for Gram Staining of Bacteria in Microbiology Laboratory
sop for Monitoring of Compressed Air/gases for microbiological analysis
sop for BET (Bacterial Endotoxin) test in Microbiology
sop for receipt storage and Determining the population of Biological indicators
sop for qualification of analyst microbiologist
sop for Bioburden test of Packing materials in Microbiology Laboratory
sop for microbiological assay of erythromycin antibiotic
sop for liquid particle counter
sop for operation and calibration of digital zone reader
sop for monitoring of ultraviolet efficiency LAF and pass box
microbiological assay of cyanocobalamin or vitamin B12
gowning procedure for microbiological testing area
swab testing of various surfaces for bioburden determination
sop for endotoxin challenge test
Hold time study protocol for sterilized media
sop for personnel Qualification protocol for aseptic area
sop for sampling and testing of drain water
Sop for Operation of Airborne Particle Counter
sop for Validation protocol of steam sterilizer autoclave
sop for pathogen detection from drain point
Sop for Analysis of Raw water Purified water water for injection and pure steam water
sop for preservatives efficacy test
sop for collection and preservation of in house isolated microorganisms
sop for Operation Calibration and Maintenance of Micropipette
sop for microbiological testing of water
sop for depyrogenation of apparatus
sop for fertility test growth promotion test of media
sop for Operation and cleaning of moist heat sterilizer
sop for monitoring by active air sampler
sop for swab sampling and testing for clean rooms in production area
sop for monitoring in microbiology laboratory
sop for Fumigation of aseptic area and microbiology lab
sop for monitoring of personnel in aseptic area
sop for maintenance of cultures
sop for Operation and cleaning of laminar bench
sop for monitoring of pure steam
sop for entry and exit procedure to m.l.t and b.e.t room
sop for storage of and use of media
sop for disposal of microbiological media and cleaning of microbiological glassware