ANNUAL GLP MEETING SCIENTIFIC INSTITUTE OF PUBLIC HEALTH - LOUIS PASTEUR 15 MAY 2000 H. BEERNAERT - J. VAN LOCO

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ANNUAL GLP MEETING SCIENTIFIC INSTITUTE OF PUBLIC HEALTH - LOUIS PASTEUR 15 MAY 2000 H. BEERNAERT - J. VAN LOCO

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H. BEERNAERT - J. VAN LOCO. PROGRAMME. EVENTS SINCE LAST MEETING. GLP INSPECTIONS AND STATUS ... IS A QUALITY MANUAL REQUIRED IN GLP? ... –

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Title: ANNUAL GLP MEETING SCIENTIFIC INSTITUTE OF PUBLIC HEALTH - LOUIS PASTEUR 15 MAY 2000 H. BEERNAERT - J. VAN LOCO


1
ANNUAL GLP MEETINGSCIENTIFIC INSTITUTE OF
PUBLIC HEALTH - LOUIS PASTEUR15 MAY 2000H.
BEERNAERT - J. VAN LOCO
2
PROGRAMME
  • EVENTS SINCE LAST MEETING
  • GLP INSPECTIONS AND STATUS
  • BELGIAN GLP COMPLIANCE MONITORING PROGRAMME
  • GLP ON INTERNET
  • QUESTIONS ON TECHNICAL ISSUES
  • MAJOR AND MINOR DEVIATIONS

HB/000515/2
3
EVENTS SINCE LAST MEETING
  • EU MEETING (18/05/1999)
  • MJV FINLANDE (31/05/1999)
  • GLP WORKSHOP (19-20/10/1999)
  • EVALUATION MJV REPORTS (OECD 2-3/12/1999)
  • OECD GLP PANEL MEETING (26-28/01/2000)
  • ROYAL DECREES

HB/20000515/03
4
EU MEETING
  • MUTUAL AGREEMENT WITH NON EU MEMBER STATES
    JAPAN, ISRAEL and CANADA
  • FINALISATION AND ADOPTION OF EU MJV REPORT
  • UPDATING LIST OF EU GLP TEST FACILITIES
  • FORMAT ANNUAL REPORTS MEMBER STATES
  • UPDATING GLP DATABASE
  • GLP STATEMENT
  • ROLE OF EMEA AS RECEIVING AUTHORITY
  • NEW EU DIRECTIVES 99/11/EU AND 99/12/EU

HB/20000515/4
5
OECD
  • PRESENTATION OF MJV REPORTS
  • MJV SCHEDULE 2000
  • MULTI-SITE STUDIES (GERMANY)
  • COOPERATION WITH WHO
  • GLP APPLICATION TO IN VITRO TOXICOLOGY STUDIES
  • INFORMATION EXCHANGE
  • TECHNICAL ISSUES
  • ACTIVITIES 2000

HB/20000515/5
6
APPROVAL OF STUDY PLAN CASE 1
TEST FACILITY SPONSOR
MANAGEMENT
QAP
STUDY DIRECTOR
TECHNICAL STAFF
OECD/19990412/4A
7
APPROVAL OF STUDY PLAN CASE 3
SPONSOR/SD/QAP
MANAGEMENT TEST FACILITY A
MANAGEMENT TEST FACILITY B
QAP
QAP
STUDY DIRECTOR
STUDY DIRECTOR
TECHNICAL STAFF
TECHNICAL STAFF
OECD/19990412/4C
8
GLP PROGRAM AND STATUS
HB/20000515/6
9
GLP ON INTERNET
  • THE OFFICIAL SITE OF THE BELGIAN GLP MONITORING
    AUTHORITY
  • - LIST OF GLP ACCREDITED FACILITIES
  • - GENERAL INFO
  • - DOWNLOADS, LINKS,
  • - MEMBERS LOGIN GLPMEMBERS
  • Http//www.iph.fgov.be/glp

HB/20000515/7
10
QUESTIONS OF TECHNICAL ISSUES
  • HOW CAN I APPLY FOR A GLP CERTIFICATE?
  • COST OF A GLP INSPECTION
  • REQUIREMENTS FOR BELTEST ACCREDITA-TION AND GLP
  • IS A QUALITY MANUAL REQUIRED IN GLP?
  • HOW CAN I OBTAIN A GLP CERTIFICATE IF I HAVE
    NEVER CARRIED OUT GLP STUDIES?

HB/20000515/8
11
QUESTIONS OF TECHNICAL ISSUES
  • CAN I SUBCONTRACT A PART OF THE STUDY?
  • DIFFERENCE BETWEEN STUDY-, PROCESS- AND
    FACILITY-BASED INSPECTION?
  • WHICH FUNCTIONS ARE REQUIRED BY GLP PRINCIPLES?
  • CAN THESE FUNCTIONS BE COMBINED BY THE SAME
    PERSON?

HB/20000515/9
12
QUESTIONS OF TECHNICAL ISSUES
  • ARE ELECTRONIC SIGNATURES AND ELECTRONIC RAW DATA
    ACCEPTED?
  • WHAT ARE SHORT-TERM STUDIES?
  • ARE ELECTRONIC COPIES AND DISTRIBUTION OF SOPS
    ALLOWED?
  • DIFFERENCE DEVIATION AND AMENDMENT?

HB/20000515/10
13
QUESTIONS OF TECHNICAL ISSUES
  • WHO SHOULD MAINTAIN CVs, JOB DESCRIPTIONS AND
    TRAINING FILES?
  • SHOULD REFERENCE STANDARDS LIKE QEIGHTS,
    THERMOMETERS, BE CALIBRATED BY EN 45001
    ACCREDITED FACILITIES?
  • HOW TO VALIDATE COMPUTERIZED SYSTEMS?

HB/20000515/11
14
FOLLOW UP INSPECTIONS
  • MAJOR DEVIATIONS (C)
  • COMMUNICATION AT THE END OF THE INSPECTION ?
    PENDING
  • CORRECTIVE ACTION WITHIN 3 MONTHS
  • - OK ? IC
  • - NOK ?? REINSPECTION ? OK ? IC
  • NOK ? NIC
  • MINOR DEVIATIONS
  • - A LOT IN ONE ISSUE ? C
  • - OTHER CORRECTIVE ACTIONS WITHIN 3 MONTHS

HB/2515/12
15
MAJOR DEVIATIONS
  • ORGANISATION AND PERSONNEL
  • - LACK OF DESIGNATION OF RESPONSIBILITIES
  • - TRAINING PROGRAMS AND RECORDS
  • QA PROGRAMME
  • - NO MASTER SCHEDULE
  • - SPECIFICATION / ASSESSMENT OF CRITICAL PHASES
  • - NO REPORTS TO MANAGEMENT AND STUDY DIRECTOR
  • - FOLLOW UP OF CORRECTIVE ACTIONS

HB/20000515/13
16
MAJOR DEVIATIONS
  • FACILITIES
  • - CONTAMINATION / INTEGRITY OF DATA
  • - ENVIRONMENTAL CONDITIONS
  • APPARATUS
  • - CALIBRATION

HB/20000515/14
17
MAJOR DEVIATIONS
  • TEST SYSTEMS
  • - PHYSICAL / CHEMICAL APPARATUS
  • - BIOLOGICAL EU, OECD, ICH GUIDELINES OR OTHERS
  • TEST ITEMS
  • - CHARACTERISTICS
  • - STABILITY, HOMOGENEITY

HB/20000515/15
18
MAJOR DEVIATIONS
  • STANDARD OPERATING PROCEDURES
  • - AVAILABILITY, APPLICATION
  • - APPROVAL
  • - USE OF OLD OR UNMANAGED PROCEDURES
  • PERFORMANCE STUDY
  • - COLLECTION OF RAW DATA BEFORE APPROVAL OF
    STUDY PLAN
  • - AVAILABILITY OF DEVIATIONS / AMENDMENTS
  • - CONSISTENCY WITH RAW DATA AND FINAL REPORT

HB/20000515/16
19
MAJOR DEVIATIONS
  • REPORT
  • - 1 STUDY PLAN - 1 REPORT
  • - APPROVAL
  • - STATEMENTS
  • - AMENDMENTS
  • ARCHIVES
  • - AVAILABILITY

HB/20000515/17
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