General Guidance
Before assigning any job responsibility to a
microbiologist, Team leader Microbiology shall qualify the microbiologist as
per qualification procedure mentioned ahead.
The microbiologist shall undergo shop floor
training for the required test before proceeding for the analyst qualification
procedure.
Before initiating analyst qualification for
the sterility test, microbial enumeration and test for specified
microorganisms, microbiologist must be qualified for gowning qualification
Analyst shall read respective procedure
thoroughly and understand the test Method written in procedure.
Qualified analyst shall explain the test
procedure. Trainee analyst shall observe the test procedure is performed by
qualified analyst.
Then trainee analyst shall perform the test
under the supervision of qualified analyst.
Team leader shall allocate the pre-analyzed
and approved codified test samples to trainee
analyst and record the test sample details and final conclusion as per Respective
log.
Trainee analyst shall perform the test
independently as per references test procedure provided by the Team leader /designee
for three consecutive samples.
Team leader shall qualify the analyst/s based
on the techniques followed, competency and test results.
If the analyst/s fails in the qualification
test, retraining shall be given and requalification shall be performed again to
qualify the analyst for microbiology.
Analyst Qualification
procedure for Sterility Test
In case of sterility only sterile
fluid A or any suitable diluents (Coded samples) shall be given to Trainee
analyst (Microbiologist).
Trainee analyst (Microbiologist)
shall perform sterility testing for the allocated three consecutive samples.
Team leader shall cross check the results
with the data & review and approve the analyst based on the test
observations.
The microbiologist stands qualified for
sterility test only if the test results meet the Acceptance criteria as per
Table I.
Analyst
Qualification procedure for Bacterial Endotoxin Test
Analyst shall be qualifying on
the basis of Lysate sensitivity (Control curve) test.
Only the previously approved lot
of Lysate shall be used for the analyst qualification.
The qualification tests shall be
performed for three consecutive times to confirm the reproducibility &
consistency of the Microbiologist/s.
Observations of the test shall be
taken in the presence of qualified Analyst/ supervisor.
Team leader /Designee shall
review the results and approve the analyst based on the results.
The analyst stands qualified for
Bacterial Endotoxin Test only if the test results meet the Acceptance criteria
given ahead under Table I.
Analyst
Qualification procedure for Test for Microbial Enumeration test
In order to qualifying a person
for the test for Microbial Enumeration test, Trainee analyst (Microbiologist)
shall perform culture qualification using suitable plating technique.
A) Pour Plating Technique:If the trainee analyst (Microbiologist) has
to be qualified for pour plating technique, Team leader / Designee shall allocate
three pre-quantified coded aerobic bacterial culture suspensions contain NMT 104
cfu per ml.
Trainee
analyst (Microbiologist) shall perform culture quantification by making serial
dilutions for 2 times of the culture suspension and pour plating each
dilution.Test shall be performed as per aseptically in Bio-safety cabinet in
culture handling room.Test data shall be recorded as in the presence of
supervisor.
Photocopy of the data of initial
standardization of the inoculum shall be attached along with the Analyst
Qualification Record.
Team leader /Designee shall
review the results and approve the analyst based on the results.
The microbiologist stands
qualified for Test for Microbial Enumeration test only if the test results meet
the acceptance criteria given ahead under Table I.
B) Membrane
Filtration Technique
If the microbiologist has to be
qualified for membrane filtration technique, Team leader / Designee shall
provide microbiologist three coded fluid A samples which may be spiked or
un-spiked.
Spiked sample/s shall contain NMT
100 cfu of the same organism.
Test shall be performed
aseptically in Bio-safety cabinet in culture handling room.
Test data shall be recorded in
the presence of supervisor.
Photocopy of the data of initial
standardization of the inoculum shall be attached along with the Analyst Qualification
Record.
Team leader /Designee shall
review the results and approve the analyst based on the results.
The microbiologist stands
qualified for Test for Microbial Enumeration test only if the test results meet
the acceptance criteria given ahead under Table I.
Analyst
Qualification procedure for Test for Specified Organisms
In order to qualifying a person
for the test for specified organisms, trainee analyst (Microbiologist) shall perform
three coded sterilized sample. One sample shall be un-spiked and two samples
spiked with NMT 100cfu of the one of the following four organisms.
E. coli
Staphylococus
aureus
Salmonella
spp.
Pseudomonas
aeruginosa
Trainee analyst (Microbiologist)
shall identify the organism in all the three samples and record the Result in
LOG.
Team leader /Designee shall
review the results and approve the analyst based on the results.
The analyst (microbiologist) stands
qualified for Test for specified organism only if the test results meet the
acceptance criteria given ahead under Table I.
Analyst
Qualification procedure for the Identification of Microorganisms by
Microbial Identification System.
In order to qualifying a trainee
analyst (microbiology) for the identification of the organisms using Microbial Identification
system, trainee analyst (microbiology) shall perform three pre-coded culture suspensions,
plate or slant of the following.
E. coli
Staphylococus
aureus
Salmonella
typhimurium.
Pseudomonas aeruginosa
Clostridium sporogenes
Candida albicans
Trainee analyst (microbiologist) shall
perform the identification test in the presence of supervisor.
Trainee analyst (microbiologist)
shall record the data in Respective qualification data.
The print out of the
identification report shall be attached along with the Respective qualification
data.
Photocopy of the data shall be
attached along with the qualification record.
Team leader /Designee shall
review the results and approve the analyst based on the results.
The analyst (microbiologist) stands
qualified for the Identification by Vitek2, if the test results meet the
acceptance criteria given ahead under Table I.
Acceptance
Criteria for the Analyst Qualification
Acceptance criteria for the analyst
qualification are as per table given below.
TABLE I
Sr. No.
|
Test
|
Acceptance criteria
|
1.
|
Sterility Test
|
Ø All the three sterile
test samples shall not show any evidence of microbial contamination.
Ø Media negative
control shall not show any evidence of microbial contamination.
Ø Media used for
the testing shall qualify the growth promotion test.
|
2.
|
Bacterial
Endotoxin Test
|
If value of the
measured sensitivity of the previously approved lot of lysate is not less
than 0.5λ and not more than 2λ, the analyst stands qualified for the testing.
|
3.
|
Microbial Enumeration test (By Pour plate/ membrane filtration)
|
Growth obtained
by the microbiologist must not differ by a factor greater than 2 from the
calculated value for the standardized inoculum in all the three replicates.
|
4.
|
Test for
specified organisms
|
Specified
Organism Identified by the Microbiologist shall match with the organism
spiked by the Head Microbiology in all the three replicates.
|
5.
|
Identification
of Microorganisms by Microbial Identification System
|
Organism
Identified by the Microbiologist shall match with the organism given by the
Head Microbiology in all the three replicates.
|
Re-qualification:
In case the analyst/microbiologist
is not performing any test for a period of more than six months, he/she
undergoes re-qualification prior to perform any test.
Before adding or changing
responsibility of the microbiologist, he/she shall be qualified for the new
test responsibility..
In case if microbiologist/analyst
is on long term leave for the period of 6 months or more.
If some OOS is observed and the
reason for the OOS has been observed to be analytical error.
Recommended
LOG
A) Details Of
Coded Sample for Analyst Qualification
Name of
the Microbiologist: _______________________________ Employee code:
__________
Test for
which Microbiologist to be Qualified:_________________________________________
|
|||
Date
|
Sample
Code
|
Sample
Details
|
Done By
|
B) Analyst
Qualification Activity Record
Name
of the Microbiologist:
|
Employee
code:
|
||||
Date
|
Training Title
|
Description
|
Trainee Sign/Date
|
Trainer Sign/Date
|
Remarks
|
C) Qualification
Data Sheet:
Name of the Microbiologist:
|
Emp. Code:
|
Test for which Microbiologist
to be Qualified:
|
|
Sample Code (if Any):
|
|
Date of Start of Qualification:
|
|
Date of Completion of
Qualification:
|
|
Reference to be followed for
testing (If any):
|
|
Results:
|
|
Comment:
|
|
Details of
Attach Raw data sheet/s:
|
|
Conclusion: Since the Results of the test performed by
the Microbiologist meets/ does not
meet the acceptance criteria hence the Microbiologist Stands qualified / not qualified.
|
|
Team leader /Designee (Sign./date)
|
|
D) List of
Qualified Analyst
Sr. No.
|
Analyst Name
|
Emp. code
|
Test / Instrument
|
Qualification status
|
Qualified On
|
Date of Re-qualification
|
Recorded By
|
Checked By
|
ABBREVIATIONS:
Sr. No.
|
Abbreviation
Used
|
Full Form
of Abbreviation
|
1.
|
cfu
|
Colony
Forming Unit
|
2.
|
LAF
|
Laminar
Air Flow
|
3.
|
No.
|
Number
|
4.
|
NMT
|
Not More Than
|
5.
|
OOS
|
Out Of Specification
|
6.
|
°C
|
Degree
Celsius
|
There are some natural remedies that can be used in the prevention and eliminate diabetes totally. However, the single most important aspect of a diabetes control plan is adopting a wholesome life style Inner Peace, Nutritious and Healthy Diet, and Regular Physical Exercise. A state of inner peace and self-contentment is essential to enjoying a good physical health and over all well-being. The inner peace and self contentment is a just a state of mind.People with diabetes diseases often use complementary and alternative medicine. I diagnosed diabetes in 2010. Was at work feeling unusually tired and sleepy. I borrowed a cyclometer from a co-worker and tested at 760. Went immediately to my doctor and he gave me prescription like: Insulin ,Sulfonamides,Thiazolidinediones but Could not get the cure rather to reduce the pain but brink back the pain again. i found a woman testimony name Comfort online how Dr Akhigbe cure her HIV and I also contacted the doctor and after I took his medication as instructed, I am now completely free from diabetes by doctor Akhigbe herbal medicine.So diabetes patients reading this testimony to contact his email drrealakhigbe@gmail.com or his Number +2348142454860 He also use his herbal herbs to diseases like:SPIDER BITE, SCHIZOPHRENIA, LUPUS,EXTERNAL INFECTION, COMMON COLD, JOINT PAIN, EPILEPSY,STROKE,TUBERCULOSIS ,STOMACH DISEASE. ECZEMA, PROGENITOR, EATING DISORDER, LOWER RESPIRATORY INFECTION, DIABETICS,HERPES,HIV/AIDS, ;ALS, CANCER , MENINGITIS,HEPATITIS A AND B,ASTHMA, HEART DISEASE, CHRONIC DISEASE. NAUSEA VOMITING OR DIARRHEA,KIDNEY DISEASE. HEARING LOSSDr Akhigbe is a good man and he heal any body that come to him. here is email drrealakhigbe@gmail.com and his Number +2349010754824
ReplyDeleteGood day everyone, If getting HIV cure was that easy then why do a lot of people still suffer from HIV?. i was diagnosed of HIV back in 2013 and i was also told it has no cure, i have been leaving with it since then, but i kept praying and doing everything possible to get cured, so i never stopped doing research about finding a cure, i came across testimonies about people getting cured through herbal medication, and i have always believe in herbs and its medical properties, after doing so many research about it i found Dr. james was the one who cured them and i discovered he was a professional in herbal medication and he has also helped many people, i contacted him, we talked on phone and i confirmed he was genuine, i did all what he told me to do, i received the medicine he sent to me through courier delivery services. used it as he has prescribed, and glory be to God almighty GOD i am completely cured now, i went back to my doctor to confirm it. Do not be deceived THERE IS A CURE FOR HIV, doctors might tell you there is no cure but WITH HERBAL MEDICATION THERE IS A CURE and if you need to know or get cured from HIV or others disease such as Herpes virus, yeast infections, Parkinson's disease,Schizophrenia,Cancer,Scoliosis,Bladder Cancer,Colorectal Cancer,Breast Cancer,Kidney Cancer,Leukemia,Lung Cancer,Skin Cancer,Uterine Cancer,Prostate Cancer,Fibromyalgia,a
ReplyDeleteSyndrome Fibrodysplasia ,Epilepsy Dupuytren's disease, Diabetes ,Coeliac disease, Angiopathy, Ataxia,Arthritis,Amyotrophic Lateral Sclerosis,Alzheimer's disease,Adrenocortical carcinoma.Asthma,Allergic diseases.Hiv_ Aids,Herpes,Inflammatory bowel disease ,Copd,Diabetes. contact Dr. James through Email: drjamesherbalmix@gmail.com And You can call/WhatsApp dr James on +2348152855846
This blog website is pretty cool! How was it made ! order Deca 300
ReplyDeleteThank you for very usefull information.. visit this page
ReplyDelete