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

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ANNUAL GLP MEETINGSCIENTIFIC INSTITUTE OF
PUBLIC HEALTH - LOUIS PASTEUR15 MAY 2000H.
BEERNAERT - J. VAN LOCO
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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
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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
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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
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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

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APPROVAL OF STUDY PLAN CASE 1
TEST FACILITY SPONSOR
MANAGEMENT
QAP
STUDY DIRECTOR
TECHNICAL STAFF
OECD/19990412/4A
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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
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GLP PROGRAM AND STATUS
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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

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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?

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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?

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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
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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?

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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
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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

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MAJOR DEVIATIONS

• FACILITIES
• - CONTAMINATION / INTEGRITY OF DATA
• - ENVIRONMENTAL CONDITIONS
• APPARATUS
• - CALIBRATION

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MAJOR DEVIATIONS

• TEST SYSTEMS
• - PHYSICAL / CHEMICAL APPARATUS
• - BIOLOGICAL EU, OECD, ICH GUIDELINES OR OTHERS
• TEST ITEMS
• - CHARACTERISTICS
• - STABILITY, HOMOGENEITY

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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

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MAJOR DEVIATIONS

• REPORT
• - 1 STUDY PLAN - 1 REPORT
• - APPROVAL
• - STATEMENTS
• - AMENDMENTS
• ARCHIVES
• - AVAILABILITY

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