Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)HadiaNaz1
EXECUTIVE SUMMARY OF ICH GUIDELINES Q5A (R1) AND Q4B ANNEX 2 (R1)
VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN – Q4B ANNEX 2 (R1):
This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. The scope of the document covers products derived from cell cultures initiated from characterized cell banks. It covers products derived from in vitro cell cultures, recombinant DNA – derived products and also includes products derived from hybridoma cells grown in vivo.
Three principal approaches have evolved to control the potential viral contamination of biotechnology products:
a) Selecting & testing cell lines and other raw materials, including media components, for the absence of undesirable viruses which may be infectious and/or pathogenic for humans.
b) Assessing the capacity of the production processes to clear infectious viruses.
c) Testing the product at appropriate steps of production for absence of contaminating infectious viruses.
The guideline suggests approaches for the evaluation of the risk of viral contamination and for the removal of virus from the product. Following are the recommended tests for the brief description of a general framework and philosophical background within which the manufacturer should justify the testing that was done;
1) Test for Retroviruses
2) In vitro Assay
3) In vivo Assay
4) Antibody Production Tests
TEST FOR EXTRACTABLE VOLUME OF PARENTRAL PREPARATIONS GENERAL CHAPTER – Q4B ANNEX 2 (R1):
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). The acceptance criteria of this document are same in the three pharmacopoeias.
The annex contains the following considerations for the implementation;
1) General Consideration
2) FDA Consideration
3) EU Consideration
4) MHLW Consideration
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)HadiaNaz1
EXECUTIVE SUMMARY OF ICH GUIDELINES Q5A (R1) AND Q4B ANNEX 2 (R1)
VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN – Q4B ANNEX 2 (R1):
This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. The scope of the document covers products derived from cell cultures initiated from characterized cell banks. It covers products derived from in vitro cell cultures, recombinant DNA – derived products and also includes products derived from hybridoma cells grown in vivo.
Three principal approaches have evolved to control the potential viral contamination of biotechnology products:
a) Selecting & testing cell lines and other raw materials, including media components, for the absence of undesirable viruses which may be infectious and/or pathogenic for humans.
b) Assessing the capacity of the production processes to clear infectious viruses.
c) Testing the product at appropriate steps of production for absence of contaminating infectious viruses.
The guideline suggests approaches for the evaluation of the risk of viral contamination and for the removal of virus from the product. Following are the recommended tests for the brief description of a general framework and philosophical background within which the manufacturer should justify the testing that was done;
1) Test for Retroviruses
2) In vitro Assay
3) In vivo Assay
4) Antibody Production Tests
TEST FOR EXTRACTABLE VOLUME OF PARENTRAL PREPARATIONS GENERAL CHAPTER – Q4B ANNEX 2 (R1):
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). The acceptance criteria of this document are same in the three pharmacopoeias.
The annex contains the following considerations for the implementation;
1) General Consideration
2) FDA Consideration
3) EU Consideration
4) MHLW Consideration
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The conference built upon the UK Diagnostics Summit held annually in London discussed how diagnostics and testing are tackling COVID-19, the technology in development, accuracy of COVID-19 tests as well as exploring current testing methods for cancer, diabetes, sepsis, urinary tract infections and HAI’S.
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book of Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology
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ABSTRACT- Enteric fever is a major public health problem in developing countries like India. An early and accurate diagnosis is necessary for a
prompt and effective treatment. We have evaluated the diagnostic accuracy of ENTEROSCREEN-WBTM as compared to Widal test in rapid and early
diagnosis of enteric fever. A total of 145 patients serum samples were tested by Rapid ENTEROSCREEN-WBTM and Widal test including clinically
suspected cases of enteric fever of all age groups. Vaccinated individuals, patients on antibiotic therapy, patients who have other associated conditions,
patients suffering from fever due to non-enteric etiology & non consent patients were excluded. The overall sensitivity, specificity, positive
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Considerations for Diagnostic COVID-19 Tests in the 4 Medical Testing Centre ...semualkaira
In this study during the coronavirus disease in 2021 (COVID-19)
pandemic, design, development, validation, verification incidence
and implementation of diagnostic tests are reported by many diagnostic tests from May until December 2021 we managed to
establish clinical validation and formal approval. In this article
we summarize the crucial role of diagnostic tests during the first
global wave of COVID-19. The technical and implementation and
diagnostics during a possible resurgence of COVID-19 in future
global waves or regional outbreaks. We continued global improvement in diagnostic test that is essential for more rapid detection of
patients, possibly at the point of care, and for optimized prevention
and treatment
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Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
The Diagnostic & Testing virtual conference held on the 11th June 2020 was an inspiring event examining the role of both molecular and rapid diagnostics in tackling disease, infection and reducing the impact of COVID-19 within our communities and hospitals. The virtual conference explored how health professionals, academics and industry are driving diagnostic and testing usage within laboratories, pharmacies and community practice.
The conference built upon the UK Diagnostics Summit held annually in London discussed how diagnostics and testing are tackling COVID-19, the technology in development, accuracy of COVID-19 tests as well as exploring current testing methods for cancer, diabetes, sepsis, urinary tract infections and HAI’S.
Antibiotic-pathogen-biomarker screening by PCR must have SACIvan Brukner
For HAI (Hospital Aquired Infections) and biomarker-screening by PCR, sample adequacy control (SAC) is ``must``. Without SAC turn arround time from screening to result might be even 2 weeks...! Keep that ion mind when baying new molecular screening platfrom.
Basic laboratory procedures in clinical bacteriologyamin beni
book of Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology Basic laboratory procedures in clinical bacteriology
Care start access bio antigen test covid 19 biotechh commerceHafsaWadood1
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ABSTRACT- Enteric fever is a major public health problem in developing countries like India. An early and accurate diagnosis is necessary for a
prompt and effective treatment. We have evaluated the diagnostic accuracy of ENTEROSCREEN-WBTM as compared to Widal test in rapid and early
diagnosis of enteric fever. A total of 145 patients serum samples were tested by Rapid ENTEROSCREEN-WBTM and Widal test including clinically
suspected cases of enteric fever of all age groups. Vaccinated individuals, patients on antibiotic therapy, patients who have other associated conditions,
patients suffering from fever due to non-enteric etiology & non consent patients were excluded. The overall sensitivity, specificity, positive
predictive value (PPV) and negative predictive value (NPV) of ENTEROSCREEN-WBTM considering Widal test as gold standard were 50% and
96%, 66.66% and 92.30% respectively. ENTEROSCREEN-WBTM was found to be significantly more specific. Although the Rapid ENTEROSCREEN-
WBTM tests are meant to diagnose of S. typhi. Ten patients who were ENTEROSCREEN-WBTM positive for S. typhi were also positive by
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Considerations for Diagnostic COVID-19 Tests in the 4 Medical Testing Centre ...semualkaira
In this study during the coronavirus disease in 2021 (COVID-19)
pandemic, design, development, validation, verification incidence
and implementation of diagnostic tests are reported by many diagnostic tests from May until December 2021 we managed to
establish clinical validation and formal approval. In this article
we summarize the crucial role of diagnostic tests during the first
global wave of COVID-19. The technical and implementation and
diagnostics during a possible resurgence of COVID-19 in future
global waves or regional outbreaks. We continued global improvement in diagnostic test that is essential for more rapid detection of
patients, possibly at the point of care, and for optimized prevention
and treatment
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The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
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Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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CLASS 11 CBSE B.St Project AIDS TO TRADE - INSURANCE
Viral loaded six month Industrial training.pptx
1. STUDENT’S INDUSTRIAL WORK EXPERIENCE SCHEME (SIWES)
TRAINING REPORT
BCH 390
UNDERTAKEN AT
CHUKWUEMEKA ODUMEGWU OJUKWU UNIVERSITY TEACHING
HOSPITAL PCR LAB AMAAKU, AWKA
ANAMBRA STATE
SUBMITTED BY
JAMES CHIDINMA VICTORIA
2020 204 247
TO THE DEPARTMENT OF BIOCHEMISTRY FACULTY OF NATURAL
SCIENCES,
CHUKWUEMEKA ODUMEGWU OJUKWU UNIVERSITY, ULI
NOVEMBER, 2023
2. OUTLINE
⚬Introduction
⚬BRIEF HISTORY OF PCR LAB(VL)
⚬Company’s Organization Chart
⚬VIRAL LOAD TEST
⚬FACTORS THAT AFFECT VIRAL LOAD TEST (V.L)
⚬Procedure
⚬Conclusion
⚬Relevance
3. INTRODUCTION
Currently, the overall HIV adult prevalence in India is 0.26% with an
estimated ~2.1 million1 PLHIV. Out of these, ~1.26 million PLHIV are
registered in the National AIDS Control Programme (NACP) and
~1.132 million are on antiretroviral therapy (ART). India is committed
to achieving the global 9090-90 target by 2020 viz. 90% of people living
with HIV would know their HIV status, 90% of people who know their
HIV status will receive treatment and 90% of people on treatment would
have suppressed viral load to minimize HIV transmission. Thus, it is
important that viral load testing is scaled up in the country to monitor
the viral load suppression.
4. ⚬BRIEF HISTORY OF PCR
LAB(VL)
The polymerase chain reaction (PCR) was developed
in 1983 by Dr. Kay Mullis while working for cetus
cooperation. In 1993, he received the noble prize in
chemistry for this important contribution that
revolutionized molecular biology (3, 4, 7, 8). The
technique can be used to amplify DNA sequences
from any type of organism. It has been adapted
over the years to allow amplification of RNA
samples as well as quantification of the amount of
5. Company’s Organization Chart
S.T.D
LAB MANAGER
SAMPLE
MANAGEMENT
TEAM
QUALITY
ASSURANCE
TEAM
DATA
MANAGEMENT
TEAM
RT-PCR
TEAM
LAB
SUPPLIES
TEAM
LAB
HEALT&SAFETY
TEAM
CLEANERS
CONSULTANT
TEAM
6. VIRAL LOAD TEST
The viral load test measures the amount of HIV in one’s blood. It is the preferred way to know if antiretroviral therapy (ART) is
working. The test measures the amount or number of HIV copies in one milliliter of blood.
The more viral particles in the blood, the faster the immune system is likely destroyed and the faster the progress toward AIDS
2.1 THREE WAYS OF VIRAL TEST
⚬Reverse Transcription-Polymerase chain reaction (RT-PCR) tesks.
⚬Branched DNA (bDNA) test
⚬Nucleric acid sequence-based amplification (NASBA)
2.2 PROCEDURE
Blood should be collected in a sterile tube using EDTA (Purple top) only.
⚬Collect about 5ml of blood sample using EDTA vacutainer tube from adult patients
⚬Specimen should be sent to testing or facility laboratory within 24 hours (ideally 6 hours) of collection to spin the blood and extract
the plasma using the centrifuge
RESULT
The normal viral load test is
<20 to 75 copies of the human immunodeficiency virus (HIV) per milliliter of blood. A normal viral load may indicate: low risk of HIV
infection.
AIM
A viral load test measures the number of HIV viral particles per milliliter of blood or determination of the number of HIV viral
particles in a patient’s blood
7. FACTORS THAT AFFECT VIRAL LOAD TEST (V.L)
The factors that can affect viral load test are;
⚬Cold
⚬Malaria
⚬Vaccinations
⚬Clotted sample
⚬Inaccurate volume of blood in the sterile tube.
3.1 EQUIPMENT USED DURING THE TRAINING
⚬Centrifuge
⚬Sterile tube (EDTA tube)
⚬BD vacutainer eclipse.
8. Procedure:
⚬*PROCEDURE*
⚬1) A healthcare expert takes a blood sample from the patient's
vein using a BD vacutainer eclipse and needle in a small quantity
into an EDTA tube.
⚬ 2) After five (5) minutes the blood will be taken to the Lab for
spinning using the centrifuge,
⚬ Then the plasma will be separated from the whole blood.
⚬3) Using a pipette, you extract a little quantity of the plasma and
pour a one or two drops into a vesitect for the test to be
conducted, to find out if the person has the infection.
9. How serious is this?
*Monitoring is essential, but a
doctor may consider levels stable.
CD4 LEVEL
300-500
Cells/ mm3
VIRAL LOAD
Less than 200 copies/ ml.
*Acceptable levels. 500-1,500 cells/mm3 Less than 20-75 copies/ ml
RESULTS OF HIV VIRAL LOAD TEST
When the viral load is high, you have more HIV in your body. This means your immune
system is not fighting HIV very well.
HIV viral load tests are used to monitor the progress of the HIV infection in a patient
and how well the treatment is working.
13. CONCLUSION
My six months Industrial training attachment at Chukwuemeka Odumegwu
Ojukwu university teaching hospital PCR lab Amaaku Awka, has been one of
the most interesting, production, instructive and educative experience in my
life. Through this training, I have gained new insight and more
comprehensive understanding about the real industrial working condition and
practice and also improved myself and functional skills.
All these valuable experience and knowledge that I gained were not only
through the direct involvements in task but also through other aspects of the
training such as work observation, supervision and interaction at the field. It
also exposed me to some certain things about medical environment.
As a result of the program, I am now more confident to build my future
career with the knowledge and experience I acquired at COOUTH PCR LAB
AMAAKU.
14. RELEVANCE
⚬Viral load as a topic to BIOCHEMISTRY.
⚬The viral load test is a key tool in monitoring and managing the
progression of viral infections such as HIV and hepatitis C.
⚬In the field of biochemistry, understanding the viral load is
crucial for studying the replication and progression of the view in
the body.
⚬Biochemist use the viral load test to study the molecular
mechanisms of viral replication and infection. By measuring the
amount of virus in different stages of the infection, scientists can
analyze how the virus interacts with host cells, identify potential
targets for antiviral therapy, and assess the effectiveness of new
drugs