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Quality Assurance & Quality Control in  Pharmaceuticals Quality Assurance & Quality Control in  Pharmaceuticals

Quality Assurance & Quality Control in Pharmaceuticals - PowerPoint Presentation

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Quality Assurance & Quality Control in Pharmaceuticals - PPT Presentation

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

gcp trial study ich trial gcp ich study clinical data quality subjects guidelines principles regulatory medical human investigator assurance

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Slide1

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