QA & QC in Clinical trial

  • View
    139

  • Download
    1

Embed Size (px)

Text of QA & QC in Clinical trial

QUALITY CONTROL AND QUALITY ASSURANCE1

WHY QA & QCTo ensure clinical data accuracy and integrity, it is necessary to thoroughly review these data, to assess the validity of data and to carefully document query identification and resolution throughout a study's duration. Maintaining accuracy and quality throughout a clinical study is a continual, dynamic process

2

Understanding Quality

3

Conformance to the standards.

DEFINITIONSby

Achieving excellence in a product/service meeting/exceeding the requirements of the customer.

A refined process in which products are assessed, improved, ensured, and confirmed. Quality means producing a defect free product from both manufacturer and customers viewpoint. "Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives."4

Good quality product Identify the needs/ requirements/ expectations of the customer

Keep the PROACTIVE PLAN in place

5

PROACTIVE PLAN

QC

QA

Make the QUALITY happen

6

Understanding Quality Control

7

QC(ICH sec 1.47) : Operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled.

8

Understanding Quality Assurance

9

QA(ICH sec 1.46) all those planned and systemic actions that are established to ensure that the trial is performed and data are generated, recorded and reported in compliance with GCP and regulatory requirements .

10

QC vs QA11

QC

QA

helps to identify abnormalities/ inconsistencies

helps to prevent abnormalities/ inconsistencies12

QC

QA

verification process

preventive process

13

QC

QA

it is the responsibility of a scientist

it is the responsibility of management14

QC

QA

will not perform QA activity.

will perform QC activities to validate the system. so also called QA over QC15

QC

Tries to find out the defects

Q U A L I T Y

QA

Tries to prevent the defects 16

BENEFITS OF QUALITY SYSTEMS

Quality improvement Work culture improvement

Teamwork Improved

Less waste and reworks productivity

Increased17

QUALITY AND STANDARDSQuality can be defined as: 1. A standard of excellence 2. Having or showing excellence 3. Superiority in performance 4. Suitability of intended purpose A more tangible definition would be ADHERENCE TO STANDARDS

18

THE QUALITY PLANThe quality plan describes how the quality control and quality assurance processes will be applied throughout the clinical trial Operational QC QC plan for each key operational stage of the study that defines standards against which QC will be conducted E.g. acceptable quality levels E.g. appropriate methods to report and distribute results.19

THE QUALITY PLANPROTOCOL REVIEW During the study design phase, QC personnel provide an independent review of the approved proposed protocol. CRF The QC plan includes comparison of the study's CRF to the objectives set forth in the protocol to ensure that it is designed to collect all necessary data CRF FILLING GUIDELINES A requirement to review CRF completion guidelines is also an element of the QC plan.

20

FOR OVERALL SITE MANAGEMENT, A COMPLETE QCPLAN ADDRESSES FOLLOWING

Investigator selection and qualifications experience in conducting clinical trials experience with the specific indication not on the FDA's restricted or debarred lists adequate staff and facilities personal involvement

21

STUDY CONDUCT (MONITORING) subject informed (signed informed consent form) subject's eligibility (inclusion/exclusion) protocol compliance adverse events (AEs) and concomitant medication drug accountability and storage

22

SOURCE DOCUMENT VERIFICATION

medical records lab data progress notes diagnostic tests

query resolution completed data clarification forms compliance with regulations

23

FIVE BASIC VARIABLES1.

2.3. 4.

5.

Man Materials Methods Equipment Environment

24

THE ROLE OF QA FUNCTION Confirm

GCP compliance Act as a catalyst for quality improvement Provide advice on GCP matters Provide help with training clinical research staff To help establish a quality and compliance based culture

25

CLINICAL TRIALS GCP ASPECTSDesign Conduct Performance Reporting

Good Clinical Practice GCP Standards

26

Monitoring

Analysis

Recording

Audits

ASSURANCE BY GCPCredibility of data Accuracy of data

ASSURANCE

Protection of Rights, Integrity & Confidentiality of Trial Subjects

27

CLINICAL TRIALS GLP ASPECTSLaboratory Records Bioanalytical Methods Controls Facilities (Laboratory)

Assurance of Compliance to Regulations (GLP aspects)

Equipment & Instruments

Personnel (Analysts)

Work Practices

28

ROLE OF QUALITY ASSURANCECOMPLIANCE TO GCP COMPLIANCE TO GLP COMPLIANCE TO OTHER APPLICABLE REGULATORY REQUIREMENT(S)

QUALITY ASSURANCE (QA)

COMPLIANCE TO STUDY PROTOCOL

COMPLIANCE TO 29 SOPs / WGs

HOW IS IT ENSURED ?Screening of Volunteers Clinical Chemistry Clinical Research Bioanalytical

Implementation of QUALITY SYSTEMS

Project Management

Technology Services

Pharmacokinetics & Biostatistics

30 Quality Assurance

HOW IS IT MEASURED / ENSURED ?In-process Audits Retrospective Audits System Audits & Other Internal Audits

Compliance to the Requirements(GCP, GLP, SOPs, Protocol and others)

Management Review Meetings

Quality Control

External Audits by Sponsors / 31 Regulatory Bodies

CLINICAL AUDIT POLICY QA

is independent to systems and persons Agreement and commitment of all QA persons. Applied on clinical trial process as well as data Audits are done during as well as after trial Applied to each part of clinical development process32

SYSTEMS AUDITS Adverse

event handling and reporting Staff training records Standard Operating Procedures Equipment records Facilities Procedural inspections Archiving33

ADVERSE EVENT HANDLING All

staff aware of reporting AE procedure SOPs available for reporting AEs Documentation to demonstrate timely and satisfactory handling of AEs Regulatory reporting requirements fulfilled

34

STAFF TRAINING Job

description must be created for each member of staff A CV Training records Organizational chart of the company Procedures and SOPs

35

STANDARD OPERATING PROCEDURESEnsure that they are consistent with: Relevant

international regulations Local requirements eg Thai FDA Guidelines such as ICH-GCP Company policies and procedures

36

EQUIPMENT RECORDS An

SOP describing the use of the equipment The service and maintenance requirements of the equipment Records to illustrate that the use, service and maintenance of the equipment occurred in accordance with requirements

37

FACILITIESCertain in-house facilities, for example , for human volunteer studies, may need to comply with specific standards. QA need to verify for compliance. Eg. ABPI guidelines on standards for the facilities in which studies on non-patient volunteers are conducted.

38

ARCHIVINGA dedicated facility An individual responsible An index of the archive contents Records of entry and data examined Data should be logged into the archive within a resonable period of time Appropriate data protection measures SOPs

39

MASTER SCHEDULEAware of planned studies and must have a copy Plans audits necessary to support the study Maintains its own audit plans study by study

40

RESPONSIBILITIES OF QA PERSONNEL Maintain

all approved protocol and SOPs and have access to up-to-date master schedule Verify Protocol Conduct audits Study based, facility, processed (record to be retained) Audit records and final reports Training organizational personnel in regulatory requirements41

RESPONSIBILITIES OF QA PERSONNEL Report

inspection report to management/study director/ principal investigator Prepare and sign a QA statement Acting as the laboratory contact point for regulatory and other inspections Maintaining record of quality assurance42

REQUIREMENTS FOR FUNCTIONING Written

SOPs Representative list Quality assurance units aims, scope and organization Selection and training of QAU SOPs Conducting study phase inspection Conducting study data inspection Conducting process inspection Final report audit Preparing QA statement43

REQUIREMENTS FOR FUNCTIONING Documented

training program Encompassing all aspects of QA work Where ever possible include on-the-job experience Training in communication techniques and conflict handling(advisable) Training documented and evaluated44

QUALIFICATION OF QA PERSONNELTraining, expertise and experience Familiar with test procedures, standards and systems Understand the basic concepts underlying the activities being monitored

45

QUALITY SYSTEMSOrganizational Structure Well defined functional departments and organograms Clearly identified and written job responsibilities of employees Continuous training to the employees

46

QUALITY SYSTEMSOperational Procedures

Quality man