By Dr Sushrut Varun Satpathy MBBS MD Assistant Professor Department of Pharmacology Sikkim Manipal Institute of Medical Sciences Good Clinical Practices An overview 28 th ID: 494444
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Quality Assurance & Quality Control in Pharmaceuticals & Healthcare Industries
By- Dr.
Sushrut
Varun
Satpathy
MBBS, MD
Assistant Professor
Department of Pharmacology
Sikkim
Manipal
Institute of Medical Sciences Slide2
Good
Clinical Practices:
An overview
28th of January 2016
2Slide3
Good Clinical Practice (GCP): Meaning
3
Good Clinical Practice (GCP) is an international ethical and scientific quality standard
for designing, conducting, recording and reporting trials that involve the participation of human subjects.
Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Slide4
The
objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.4Slide5
History
Why Do We Need Guidelines?
Why Are We Regulated?Slide6
Nazi Medical War Crimes:
during World War II
Experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjectedSlide7
7Slide8
8
THE DOCTORS TRIALSlide9
The Tuskegee Syphilis StudySlide10
The Tuskegee Syphilis Study
Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis studySlide11
The Jewish Chronic Disease Hospital StudySlide12
The Willowbrook StudySlide13
Thalidomide tragedy
13Slide14
The thalidomide tragedy marked a turning point in toxicity testing
, as it prompted United States and international regulatory agencies to develop
systematic toxicity testing protocolsThe thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place
14
Thalidomide tragedySlide15
Codes and Guidelines
Nuremberg Code
(1947).
W.M.A’s
Declaration of Helsinki (1964).Belmont Report
(USA) (1979)-Tuskegee syphilis study
C
ouncil for
I
nternational
O
rganizations of
M
edical
S
ciences (
CIOMS)
1993.
I
nternational
C
onference on
H
armonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
(ICH)
,
in
1996
,
Guideline on
G
ood
C
linical
P
ractice
,E6
(GCP).
Slide16
Overview
of ICH GCPSlide17
What is ICH?
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)-
is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.
17Slide18
What is ICH?
Since its inception in 1990, ICH has gradually evolved
ICH's mission is to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient mannerSlide19
How did it evolve?
The need to harmonize
Public disasters, serious fraud and abuse of human rights. Trials of War criminals-Nuremberg code 1947
Thalidomide- Declaration of Helsinki 1964Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis studySlide20
Key objective
To discuss and define the minimum standards for the development and registration of investigational productsSlide21
The result?
Many guidelines made
Most important- ICH GCP guidelinesEvolved in several stepsSlide22
Sources and development of GCP guidelinesSlide23
What is GCP?
A standard for the design, conduct, performance, monitoring ,auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible, accurate and that the rights, integrity and confidentiality of trial subjects are protected.Slide24
Why is it needed ?
To avoid research misconduct and fraud as this is a growing public and professional concern nowadays
Compliance with this standard provides public assurance that the rights, safety and well being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of HelsinskiSlide25
Why is it needed?
To assure that the clinical trial data are credible
To provide a unified standard for different countries to facilitate the mutual acceptance of clinical data by regulatory authorities Slide26
Principles of GCP-ICH
GCP
Ethical conduct as perDeclaration of HelsinkiGCP
Regulatory RequirementsRisk- BenefitPrimary concern- SubjectSlide27
Principles of ICH GCP
Supportive data
Protocol
Scientifically sound, clear, detailedEthical Clearance
Study to be conducted in compliance to the protocol which has received EC approvalSlide28
Principles of ICH GCP
Subject Care
Medical decisions responsibility of qualified physicianQualified staffBy education, training, experience in their area of responsibilityInformed ConsentSlide29
Principles of ICH GCP
Clinical Trial data
Recorded, handled and stored to enable accurate reporting, interpretation and verificationConfidentialitySlide30
Principles of ICH GCP
Investigational Product
Manufactured, handled and stored as per GMPQuality Assurance
Systems and procedures to ensure the Quality of every aspect of the trialSlide31
Indian GCP guidelines
Released in Dec 2001(Developed by
CDSCO and endorsed by DCGI)In general, in line with ICH GCPSlide32
The Players
Under the GCP guidelines-
Institutional Review Board/ Ethics Committee,Investigators Sponsor(s)Slide33
Institutional Review Board/Ethics Committee
Responsibilities :
Safeguard rights, safety and well being of all trial subjectsTrial protocol(s)/ amendment(s), written informed consent form(s), subject recruitment form(s), written information to be provided to the subjects, investigator’s bronchure(IB), available safety information, information about payments and compensation, investigator’s CV Slide34
IRB/EC…responsibilties ..cont..
Review a proposed clinical trial within a reasonable time
Review each ongoing trial at intervals appropriate to the degree of risk to human subjects, but atleast once per yearAddress relevant ethical concerns and meet applicable regulatory requirements for such trials Review both amount and method of payment to subjects*Slide35
Investigator
Qualified by education, training and experience
Appropriate use of the investigational product(s), aware of and comply with GCP and regulatory requirement(s) Permit monitoring and auditing by the sponsor, and inspection A qualified physician (investigator/sub-investigator) – responsible for trial related decisionsSlide36
Investigator …..cont…
Comply with the sponsors for timely completion of the project and recording of all clinical and non-clinical data
ADR- managed appropriately and reported On Trial completion - * inform institution * documents/records – sponsor * IRB/EC- summary Slide37
Study Documentation
During the study
The investigator must keep:
Source documentsMedical records (including access to computer records)Laboratory reports
ECGs, X-rays, etc.Any other medical records, reports or notes (hospital admissions and discharges)A subject identification list
Copies of all study related documentationSlide38
Medical Records
In particular, they should contain notes on:
Sufficient information to support subject eligibilityThis should be well documented (signed and dated)
Subject’s participation in the studyDates of visitsProcedures, investigations done
Observations, diagnosesMedications taken (including study medication)Adverse events
Completion or withdrawal (reason) from the studySlide39
Study Documentation
After the study
The sponsor needs from the investigator:
Final drug accountability recordsAll used and unused supplies and medicationAll required documents completedSlide40
Sponsor
Responsiblities
: Quality assurance and Quality control : responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data generated , documented and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s) Slide41
Sponsor….responsibilities…cont…
Contract Research Organization (CRO):
May transfer any or all of sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibilty for the quality and integrity of trial data always resides with the sponsor Slide42
Sponsor…respon…cont…
Medical expertise
Trial design Trial management, data handling, record keeping Independent data monitoring committeeInvestigator selection Allocation of duties and functionsCompensation to subjects and investigatorsSlide43
Sponsor…respon…cont…
Financing
Notification/submission to regulatory authority Information on investigational productManufacturing, packaging, labeling, coding, supplying and handling investigational productRecord accessSafety information
ADR monitoring Trial monitoring and auditPremature termination or suspension of a trialSlide44
Conclusion
Scientific community involved in all types of clinical trials must be aware of and comply with the specification described in details in the guidelines for GCP before conducting any trial
Slide45
Conclusion
45
Thanks.....
“When a doctor [goes] wrong, he is the first of criminals. He has nerve and he has knowledge.”
- Sherlock Holmes Slide46
References:
http://www.wma.net/e/policy/b3.htm
www.hhs.gov/ohrp/humansubjects/guidance/belmont
.htmlwww.hhs.gov/ohrp/references/nurcode.html
www.icmr.nic.in/guidelines/GCLP
www.cdsco.nic.in/
www.ub.edu/recerca/Bioetica/doc/Declaracio_
Helsinki
_2013
www.jewishvirtuallibrary.org/jsource/Holocaust/
nazi
_
experiments
www.
ich
.org/fileadmin/Public_Web.../
ICH
.../E6_R1__Guideline