1. Subject Code: 18BBTDC501
Subject Name: Molecular Diagnosis
and Drug Designing
Course: B.Sc. Biotechnology
Semester: V
Unit 4: Genetic tools and Quality system
Topic: Good Clinical Practices (GCP): Basic concept and
framework
Faculty: Dr. Anmol Kumar
Department of Biotechnology
Atmiya University, Yogidham Gurukul, Kalawad Road, Rajkot-360005 Date: 12/10/2020
2. GLP, GCP, and GMP Regulation
• GLP, GCP, and GMP regulations used for evaluation for different purposes.
• The GLPs are designed to protect scientific data integrity and to provide the
Environmental Protection Agency (EPA) or FDA with a clear and auditable
record of open-ended research studies.
• The GCPs are intended to be an ethical and scientific quality standard for
designing, conducting, recording, and reporting studies that involve the
participation of human subjects.
• Finally, the GMPs are intended to demonstrate to the FDA whether or not
individual batches of a regulated product are manufactured according to pre-
defined manufacturing criteria.
4. Good Clinical Practices
• Clinical trials are a type of research that studies new tests and treatments and
evaluates their effects on human health outcomes.
• Good Clinical Practices (GCP) is an international ethical & scientific quality
standard for designing, conducting, recording & reporting clinical trials for
the new drug that involve the participation of human subjects.
• Compliance with this good practice provides assurance that the rights, safety
and well-being of trial subjects are protected, and that the results of the clinical
trials are credible, and that the rights, integrity, and confidentiality of trial
subjects are protected.
Goals of GCP
• To protect the rights, safety and welfare of humans, participating in research.
• To assure the quality, reliability and integrity of data collected
• To provide standards and guidelines for the conduct of clinical research
• Good Clinical Practice = Ethics + Quality Data
5. Foundations for Good Clinical Practices
• The Nuremberg Code (1947)
• The Declaration of Helsinki (1964)
• The Belmont Report (1979)
• International Conference on Harmonisation (ICH-GCP)
• International Standards Organization 14155
• Code of Federal Regulations
6. Nurenbuerg Code
• Voluntary, well-informed, understanding consent of the human subject in a
full legal capacity are required.
• The experiment should aim at positive results for society that cannot be
procured in some other way.
• It should be based on previous knowledge (like, an expectation derived from
animal experiments) that justifies the experiment.
• The staff who conduct or take part in the experiment must be fully trained and
scientifically qualified.
• The experiment should be set up in a way that avoids unnecessary physical and
mental suffering and injuries.
• The risks of the experiment should be in proportion to (that is, not exceed) the
expected humanitarian benefits.
• The human subjects must be free to immediately quit the experiment at any
point when they feel physically or mentally unable to go on.
7. Declaration of Helsinki
• Research must confirm to scientific principles.
• Protocol and independent ethical committees.
• Supervision and conduct of trial by suitably qualified persons.
• Objectives and possible benefits balanced against risk to subjects.
• Privacy respected and minimal physical and impact on the subject.
• Informed consent
• Well-being of subject takes precedence – Respect for persons.
• Protection of subjects health and rights.
• Special protection for vulnerable populations
8.
9. Belmont Report Ethical Principles
• Respect for Persons
• Informed consent
• Protection of vulnerable populations
• Beneficence (Beneficence is a concept in research ethics which states that
researchers should have the welfare of the research participant as a goal of
any clinical trial or other research study)
• Non-malfeasance
(Malfeasance is the act of knowingly committing a wrongful act.)
• Justice-Fairness
10. The International Conference on Harmonisation
(ICH-GCP)
• International Conference on Harmonisation (ICH) provided the international
quality standard GCP.
• Goals: Harmonize technical procedures and standards; improve quality;
speed time to market.
• In 1997, the FDA endorsed the GCP Guidelines developed by ICH.
• ICH guidelines have been adopted into law in several countries.
• There are 13 principle of ICH-GCP.
11. 13 Principles of ICH-GCP
Ethics:
1. Clinical trials should be conducted in accordance with the ethical principles
that have their origin in the Declaration of Helsinki, and that are consistent
with GCP and the applicable regulatory requirement(s)
2. Benefits justify risks- Before a trial is initiated, foreseeable risks and
inconveniences should be weighed against the anticipated benefit for the
individual trial subject and society. A trial should be initiated and continued
only if the anticipated benefits justify the risks
3. Rights, safety, and well-being of subjects prevail- The rights, safety, and
well-being of the trial subjects are the most important considerations and
should prevail over interests of science and society.
12. Protocol and science:
4. The available nonclinical and clinical information on an investigational
product should be adequate to support the proposed clinical trial.
5. Clinical trials should be scientifically sound, and described in a clear,
detailed protocol.
Responsibilities:
6. A trial should be conducted in compliance with the protocol that has received
prior institutional review board (IRB)/independent ethics committee (IEC)
approval.
7. Medical care given to, and medical decisions made on behalf of, subjects
should always be the responsibility of a qualified physician
8. Each individual involved in conducting a trial should be qualified by
education, training, and experience to perform his or her respective task(s).
13 Principles of ICH-GCP
13. Informed Consent:
9. Freely given informed consent should be obtained from every subject prior to
clinical trial participation
Data quality and integrity:
10. All clinical trial information should be recorded, handled, and stored in a
way that allows its accurate reporting, interpretation and verification
11. The confidentiality of records that could identify subjects should be
protected, respecting the privacy and confidentiality.
12. Investigational products should be manufactured, handled, and stored in
accordance with applicable good manufacturing practice (GMP). They should
be used in accordance with the approved protocol.
Quality Control/Quality Assurance
13. Systems with procedures to ensure quality of every aspect of the trial.
13 Principles of ICH-GCP
14. International Standards Organization (ISO)
• The International Organization for Standardization (ISO) is an international
nongovernmental organization made up of national standards bodies; it
develops and publishes a wide range of proprietary, industrial, and
commercial standards and is comprised of representatives from various
national standards organizations.
• ISO 14155: Clinical Investigation of Medical Devices for Human Subjects
– Assists sponsors, monitors, and clinical investigators in the design and conduct of
device clinical investigations
– Assists regulatory bodies and ethics committees in their roles of reviewing clinical
investigational plans
15. Who is responsible for GCP compliance?
• Sponsors
• Clinical Investigators (CIs)
• Independent Ethics Committees (IECs)
• Institutional Review Boards (IRBs)
• Contract Research Organizations (CROs)
• Research nurses
• Clinical Research Coordinators (CRCs)
• Clinical Research Associates (CRAs)
• Medical monitors
• Data entry personnel
• Others
16. Quality Control vs. Quality Assurance
⮚ Quality control emphasizes testing of products to uncover defects and
reporting to management who decides whether to allow or deny product
release.
⮚ Quality assurance attempts to improve and stabilize production and its
associated processes to avoid, or at least minimize, issues which led to the
defect(s) in the first place
17. ⮚Quality control is a product based approach.
⮚Quality control is all about the detection of defects and to verify the quality
of the product.
⮚Quality control identifies the defects after the product is produced but is
not yet released or is still in the production phase.
Quality Control vs. Quality Assurance
⮚ Quality assurance is a process based approach whose prime objective
is to prevent defects in deliverables in the planning process itself to
avoid the rework, which costs a lot.
⮚ Training, process definition, selection of tools, etc are example of a
quality assurance process.
⮚ Quality assurance is all about prevention to avoid the defect in the
first place.
⮚ The goal of the quality assurance process is to develop a process so
that defects do not arise during its production.
