Quality Assurance & Quality Control in Pharmaceuticals

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Quality Assurance & Quality Control in Pharmaceuticals




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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

2

Slide3

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.

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Slide5

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 subjected

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THE DOCTORS TRIAL

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The Tuskegee Syphilis Study

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The Tuskegee Syphilis Study

Belmont report 1978

(Ethical Principles and guidelines for the protection of human subjects of research)-

Tuskegee syphilis study

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The Jewish Chronic Disease Hospital Study

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The Willowbrook Study

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Thalidomide tragedy

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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

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Thalidomide tragedy

Slide15

Codes and Guidelines

Nuremberg Code (1947). W.M.A’s Declaration of Helsinki (1964).Belmont Report (USA) (1979)-Tuskegee syphilis studyCouncil for International Organizations of Medical Sciences (CIOMS) 1993.International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), in 1996, Guideline on Good Clinical Practice,E6 (GCP).

Slide16

Overview

of

ICH GCP

Slide17

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.

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Slide18

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 manner

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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

1964

Belmont report 1978 (

Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis study

Slide20

Key objective

To discuss and define the minimum standards for the development and registration of investigational products

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The result?

Many guidelines made

Most important- ICH GCP guidelines

Evolved in several steps

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Sources and development of GCP guidelines

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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.

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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

Helsinski

Slide25

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 per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

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Principles of ICH GCP

Supportive data

Protocol

Scientifically sound, clear, detailed

Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Slide28

Principles of ICH GCP

Subject Care

Medical decisions responsibility of qualified physician

Qualified staff

By education, training, experience in their area of responsibility

Informed Consent

Slide29

Principles of ICH GCP

Clinical Trial data

Recorded, handled and stored to enable accurate reporting, interpretation and verification

Confidentiality

Slide30

Principles of ICH GCP

Investigational Product

Manufactured, handled and stored as per

GMP

Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Slide31

Indian GCP guidelines

Released in Dec 2001(Developed by

CDSCO

and endorsed by DCGI)

In general, in line with ICH GCP

Slide32

The Players

Under the GCP guidelines-

Institutional Review Board/ Ethics Committee,

Investigators

Sponsor(s)

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Institutional Review Board/Ethics Committee

Responsibilities :

Safeguard rights, safety and well being of all trial subjects

Trial 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 year

Address 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 decisions

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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 DocumentationDuring the study

The investigator must keep:

Source documents

Medical 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 documentation

Slide38

Medical Records

In particular, they should contain notes on:

Sufficient information to support subject eligibility

This should be well documented (signed and dated)

Subject’s participation in the study

Dates of visits

Procedures, investigations done

Observations, diagnoses

Medications taken (including study medication)

Adverse

events

Completion or withdrawal (reason) from the study

Slide39

Study DocumentationAfter the study

The sponsor needs from the investigator:

Final drug accountability records

All used and unused supplies and medication

All required documents completed

Slide40

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 committee

Investigator selection

Allocation of duties and functions

Compensation to subjects and investigators

Slide43

Sponsor…respon…cont…

Financing

Notification/submission to regulatory authority

Information on investigational product

Manufacturing, packaging, labeling, coding, supplying and handling investigational product

Record access

Safety information

ADR monitoring

Trial monitoring and audit

Premature termination or suspension of a trial

Slide44

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

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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.htmwww.hhs.gov/ohrp/humansubjects/guidance/belmont.htmlwww.hhs.gov/ohrp/references/nurcode.htmlwww.icmr.nic.in/guidelines/GCLPwww.cdsco.nic.in/www.ub.edu/recerca/Bioetica/doc/Declaracio_Helsinki_2013www.jewishvirtuallibrary.org/jsource/Holocaust/nazi_experimentswww.ich.org/fileadmin/Public_Web.../ICH.../E6_R1__Guideline

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