This document discusses Good Automated Laboratory Practices (GALP) which provide guidance for managing automated regulated laboratories. It outlines the importance of standard operating procedures, documentation, logs, training, and concludes that GALP helps streamline laboratory processes and ensures work can be done efficiently within shorter timeframes. Key aspects of GALP covered include security, data management, error handling, change control, archiving, backup and recovery, and hardware maintenance.
Clinical Research Regulation in European Union ShantanuThakre3
- On 16 April 2014, the European Commission adopted the new Clinical Trial Regulation (EU No 536/2014), repealing Directive 2001/20/EC.
- Although the Clinical Trial Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit.
- The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
Clinical Research Regulation in European Union ShantanuThakre3
- On 16 April 2014, the European Commission adopted the new Clinical Trial Regulation (EU No 536/2014), repealing Directive 2001/20/EC.
- Although the Clinical Trial Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit.
- The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
Herbal products, also known as botanical products or phytomedicines, are products made from plants to treat diseases or maintain health.
Herbal products are made by extracting active ingredients from plant parts, such as leaves, bark, roots, seeds, or flowers.
Herbal products, including dietary supplements, are regulated by the FDA. However, unlike pharmaceutical drugs, they do not require pre-market approval. Instead, manufacturers are responsible for ensuring the quality and safety of their products.
The FDA establishes Good Manufacturing Practices (GMP) regulations for dietary supplements to ensure quality control during manufacturing.
The safety of herbal products in the USA is overseen by various regulatory agencies, primarily the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
To ensure a high degree of safety and effectiveness of herbal products and quality control standards during the manufacturing of herbal supplements and medicines, AHPA published GACP (Good Agriculture and Collection Practices) guideline in the American Herbal Pharmacopoeia.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Security 101: IBM i Security Auditing and ReportingPrecisely
IBM i journals and logs are the trusted source of audit information accepted by IBM i security and audit professionals as they contain a trail of access attempts, command line activity, changes to sensitive data, changes to system objects and more. However, IBM i log files contain massive amounts of data - and they are difficult to setup, report and alert on.
View this webcast on-demand to learn more about key topics such as:
• Key IBM i logs
• Auditing and monitoring for security incidents
• Leveraging 3rd party solutions that analyze security data
• How Syncsort can help
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
Herbal products, also known as botanical products or phytomedicines, are products made from plants to treat diseases or maintain health.
Herbal products are made by extracting active ingredients from plant parts, such as leaves, bark, roots, seeds, or flowers.
Herbal products, including dietary supplements, are regulated by the FDA. However, unlike pharmaceutical drugs, they do not require pre-market approval. Instead, manufacturers are responsible for ensuring the quality and safety of their products.
The FDA establishes Good Manufacturing Practices (GMP) regulations for dietary supplements to ensure quality control during manufacturing.
The safety of herbal products in the USA is overseen by various regulatory agencies, primarily the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
To ensure a high degree of safety and effectiveness of herbal products and quality control standards during the manufacturing of herbal supplements and medicines, AHPA published GACP (Good Agriculture and Collection Practices) guideline in the American Herbal Pharmacopoeia.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Security 101: IBM i Security Auditing and ReportingPrecisely
IBM i journals and logs are the trusted source of audit information accepted by IBM i security and audit professionals as they contain a trail of access attempts, command line activity, changes to sensitive data, changes to system objects and more. However, IBM i log files contain massive amounts of data - and they are difficult to setup, report and alert on.
View this webcast on-demand to learn more about key topics such as:
• Key IBM i logs
• Auditing and monitoring for security incidents
• Leveraging 3rd party solutions that analyze security data
• How Syncsort can help
Federal Webinar: RMF, DISA STIGs, and NIST FISMA Compliance using SolarWindsSolarWinds
In this webinar SolarWinds shared how to use our tools to improve your agency’s Risk Management Framework (RMF), NIST 800-53 controls, FISMA, and DISA STIGS compliance. Our solutions can help you implement, assess, and monitor your security controls. We also continuously monitor your networks, systems and application for compliance, and we provide tools to automate remediation and reporting.
Our federal Sales Engineers reviewed security controls where our tools provide support, and demonstrate how to utilize product features to meet your compliance needs. We plan to discuss Access Controls, Audit and Accountability, and Configuration Management controls, as well as Incident Response, System Maintenance, Media Protection, and other controls.
You'll learn how SolarWinds tools can help you:
• Satisfy controls or help implement and manage controls using Network Configuration Manager (NCM), and Patch Manager
• Make sure controls have been implemented correctly using NCM, and Log & Event Manager (LEM), our powerful SIEM
• Monitor that controls are working as expected using LEM, Network Performance Monitor, and NCM
• Quickly and easily produce out-of-the-box compliance reports for DISA STIGS, FISMA, and more
The Security Policy Management Maturity Model: How to Move Up the CurveAlgoSec
Rising network complexity and increased demands on business agility are rapidly hindering the traditional approach to managing security policies. The Security policy management maturity model can help you better understand your current network environment and provide you with a roadmap for improving both your security AND agility. Learn:
- The four stages of the maturity model
- How to compare your environment to the different stages
- Tips for orchestrating security policy management
- Real-life examples of benefits achieved by "moving up the curve"
Enterprise Asset Management- Mobility Readiness ChecklistUnvired Inc.
We have prepared a comprehensive checklist that helps you with your mobility readiness check for Enterprise Asset Management. Unvired mobility checklist for Enterprise Asset Management is a compilation of experience in implementing Mobile EAM for more than a decade across the globe.
PCI DSS mandates organizations to make compliance a business as usual activity instead of an annual audit. ControlCase covers the following:
- PCI DSS requirements that can be made business as usual
- PCI DSS processes that can be made business as usual
- Techniques and methodologies
- Evidence to be provided to QSA for compliance
- Key success factors
- Challenges
Making PCI V3.0 Business as Usual (BAU)ControlCase
ControlCase GRC (CC-GRC) is a flexible platform that provides an integrated solution to managing all aspects related to Governance, Risk Management and Compliance Management in any sized organization. The platform consists of several integrated modules that enable various aspects of GRC management such as Compliance Management, Vendor Management, Audit Management, Policy Management, Asset Management and Vulnerability Management.
CC-GRC allows organizations to implement one or all modules at their own pace.
Nagios Conference 2007 | Enterprise Application Monitoring with Nagios by Jam...NETWAYS
IT infrastructure such as switches and servers is the traditional focus of network monitoring tools. Increasingly organisations are focusing on monitoring business critical applications sitting on top of this infrastructure.
Altinity have deployed their Opsview software in a number enterprise environments to ensure availability of business critical applications and capture data for capacity planning. We will explain how we approach monitoring in these environment and what challenges we encounter. Opsview is an Open Source monitoring solution based on Nagios. Altinity are the commercial organsiation behind Opsview.
Obtener información sobre la actividad de la red y mantenerse al tanto del registro del firewall es una tarea desafiante ya que la herramienta de seguridad genera una gran cantidad de registros de tráfico. Presentamos Firewall Analyzer, un software de gestión de configuraciones y análisis de registros que permite a los administradores de redes comprender cómo se usa el ancho de banda en su red. Firewall Analyzer es independiente del proveedor y es compatible con casi todos los firewalls de red de código abierto y comercial como Check Point, Cisco, Juniper, Fortinet, Palo Alto y más.
Monitoring and Reporting for IBM i Compliance and SecurityPrecisely
Today’s world of complex regulatory requirements and evolving security threats requires you to find simple ways to monitor all IBM i system and database activity, identify security threats and compliance issues in real time, produce clear and concise reports, and maintain an audit trail to satisfy security officers and auditors.
IBM i log files and journals are rich sources of system and database activity. However, they are in their own proprietary format, and they are not easy to manually analyze for security events.
Join this webinar to learn more about:
- Key IBM i log files and static data sources that must be monitored
- Automating real-time analysis of log files to identify threats to system and data security
- Integrating IBM i security data into SIEM solutions for a clear view of security across multiple platforms
How Logilab SDMS helps Laboratories to enable GLP Compliance - 4Agaram Technologies
GLP lays down a very important principle that the data captured or entered in the system
must be accurate. In order to ensure accuracy, GLP necessitates computerized system
must have the capability to validate, verify and filter the data for accuracy. Logilab SDMS
ensures that users can verify the data that is captured from the instruments can go through
a workflow process. Using the workflow tool users will be guided to follow the review and
approval processes so that data errors can be avoided.
Want to learn how to improve your agency's Risk Management Framework (RMF), NIST 800-53 controls, FISMA, and DISA Security Technical Implementation Guides (STIGS) compliance? Are you interested in implementing, assessing, and monitoring agency security controls to better defend against cyberattacks? Want to continuously monitor agency networks, systems, and applications for compliance and have tools available to help automate remediation and improve reporting?
If you answered yes to one or all the above, look at this information-packed webinar. We reviewed each of the six steps of the Risk Management Framework process and demonstrated how available tools can be used to help meet security guidelines and objectives throughout the entire process. The discussion will include tools for:
• Network Configuration Management
• IT Asset Inventory
• DISA STIGS and NIST FISMA Compliance
• Patch Management
• Port Monitoring and Management
• Continuous Monitoring
• Reporting/Documentation in Support of Security Audits
Federal Webinar: Security Compliance with SolarWinds Network Management ToolsSolarWinds
In this webinar attendees learned how to use our fault, performance and configuration management tools to improve your IT security posture. Our solutions help manage and monitor network devices and their configurations to enhance risk management, IT security and compliance. Discussions will include simplifying day-to-day operations, increasing automation, and generating reports to verify compliance and highlight violations.
Our federal Sales Engineers reviewed and demonstrated how our tools can help achieve and maintain RMF, FISMA and DISA STIG compliance. Configuration management helps agencies develop, deploy and maintain compliant configurations. Fault, performance, and log management help ensure that devices are continuously monitored and operating correctly. And patch management automates patching to reduce vulnerabilities. Attendees learned how SolarWinds tools can help you:
• Leverage Network Configuration Manager (NCM), and Patch Manager to satisfy security controls or help implement and manage controls
• Utilize NCM, and Log & Event Manager (LEM), our powerful SIEM, to verify that controls have been implemented correctly
• Employ LEM, Network Performance Monitor, and NCM to monitor that controls are working as expected
• Quickly and easily produce out-of-the-box compliance reports for DISA STIGS, FISMA, and more
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
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.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
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.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
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The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
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Phyto-Pharmacological Screening, New Strategies for evaluating
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The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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GALP SOP’s
The minimum SOP topics are –
Security
Raw Data
Data Entry
DataVerification
Error Codes
Data Change Control
Data Archiving
Backup and Recovery
Hardware Maintenance
Electronic Reporting Specifics
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Security –
– 2 types : System access security and Physical Security
– Focus:
• Primarily on the computer room.
• Any related workstations.
– Physical Security
– System Access Security
Raw Data –
– Raw data is also known as primary data.
– Working definition used within the laboratory.
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Data Entry –
– Procedures related to data entry is the identification of
the person/personnel entering the system.
DataVerification –
– Verification of the Input Data.
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Error Codes –
– Interpretation of any error messages.
Data Change Control –
– Include –
• Documentation of how the authorised changes are
carried out.
• Proof that the changes do not represent changes that
could lead to the loss or corruption of data.
• Cost, scheduling and impact statements.
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Data Archiving –
– Define the procedures to ensure that the data is
stored in a clear, logical, repeatable manner.
Backup and Recovery –
– Primary aim is to ensure the integrity and
availability of the stored data in the event of
serious breach of security or a system wide
failure.
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Hardware Maintenance –
– SOP’s pertaining to efficient functioning of
Hardware.
Electronic Reporting Specifics –
– Standards, protocols and the procedures used in
the collection of data and analysis.
Additional Standard Operating Procedures
Requirements
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DOCUMENTATION IN GALP
The purpose of GALP is to
provide a vehicle for
demonstrating system
control. Documentation is an
important cog in the wheel
when it comes to GALP.
In general, six categories of
documents are specified and
required for compliance with
GALP guidelines.They are as
follows –
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Personnel:
– Personnel records help support the competence of
various employees assigned to the system
responsibilities.
Equipment:
– A hardware description log records
– A record of acceptance testing
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Operations:
– A security risk document identifies the likely and
possible risks to the security of computer-
resident data.
Facilities:
– A written environmental specifications guard
against data loss or corruption from various
environmental threats.
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Software:
– Documents for ensuring the continual functioning
of the software.
Operational Logs:
– Backup and recovery logs and drills help guard
against data loss or corruption.
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LOGS AND RELATED FORMS
Logs are used to document regular,
incremental or complete backups or changes
or performance data of the systems as well as
other elements in the laboratory.
To safeguard existing data against the risk of
future loss of data in the event of system
failure or application failure.
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Types of Logs –
– System Backup Log –
• Documents, regularly, complete or incremental system
backups.
– Routine SoftwareTesting Log –
• Records the changes made to the system software.
– User Problem Log-
• Records user related problems with the systems or
related softwares.
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– System maintenance Log –
• Records the preventative maintenance completed on particular
hardware.
– Training Log –
• Documents all the user training related information.
– Security Log –
• Used to track and identify visitors, consultants, contractors and
other nonemployees who are currently in the premises.
– Data Change Log-
• Used to record all changes made to the data in the system.
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TRAINING
Training documents are helpful in the training
of new users.
Orientation training for individuals or groups
of users of new systems or new version of
existing systems.
Training programs should be comprehensive.
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CONCLUSION
GALP provides important guidance for the
management of automated regulated laboratory.
GALP’s serve as important interpretive material in
applying the content and principles of the GLP’s to the
realities of the modern laboratory.
GALP’s have provided the much needed impetus to
the modernisation of laboratory work and have
ensured that work can be carried out in an efficient
manner within relatively shorter time.
Streamlining of processes to has been one of the
major successes of the GALP’s.
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REFERENCES
Sandy Weinberg, Good Laboratory Practice Regulations,
Informa Healthcare, 52 Vanderbilt Avenue New York, P.No
131-150
2185 good Automated Laboratory Practices Principles And
Guidance to Regulations for Ensuring Data Integrity in
Automated Laboratory Operations with Implementation
Guidance 1995 Edition.
url:https://nepis.epa.gov/Exe/ZyPDF.cgi/2000AOGI.PDF?Dockey=
2000AOGLPDF (accessed on 25 October 2017)
GALP Regulatory Handbook, Sandy Weinberg, Lewis
Publishers e-book
url:https://books.google.co.in/books?id=RfzlISKm581EC&printse
c=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q
&f=false (Accessed on 25th October 2017)
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