glp-key issues from the point of view of a test facility · test item does not need to be prepared...
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OECD OECD EventEvent, Villa , Villa TuscolanaTuscolana, Frascati (Roma), , Frascati (Roma), ItalyItaly, , AprilApril 10 10 –– 11,11, 2008 2008
Bayer CropScience, GermanyBayer CropScience, Germany
[email protected]@bayercropscience.com
GLPGLP--key issues from the point of key issues from the point of view of a test facilityview of a test facility
KathrinKathrin ErtzErtz, Martina , Martina PreuPreu
OECD Workshop: Ertz, Preu • March 2008 Slide 2
Special thanks to…
Dr. Ulrich SchepersBASFHead of Global Process &Quality AssuranceCrop ProtectionLimburgerhof, Germany
Dr. Arnold PaessensBayer HealthCareHead of GLP ManagementGlobal R&D QualityElberfeld, Germany
Dr. Barbara PohlMerckInstitute of ToxicologyHead of Quality AssuranceDarmstadt, Germany
…many discussion partners in Bayer CropScience (BCS):Gilbert Odaglia, Head of GLP QA Toxicology FranceDebra M. Wallace, Head of GLP QA USAMarcelo Vasconcelos, Head of GLP QA BrazilSandra Berghman, Head of GLP QA BioScience BelgiumAndrew Lynch, Head of GLP QA Australia
…and in the German industry:
OECD Workshop: Ertz, Preu • March 2008 Slide 3
Interpretation of “the GLP standard”GLP – an International standard with national interpretations –Example of a worst-case-studyArchiving requirementsGLP & IT: speed of development & acceptance
Sustainable GLP in “non-GLP” countries
Topics
OECD Workshop: Ertz, Preu • March 2008 Slide 4
GLP - a worldwide standardized system…?
GLP GLPGLP
OECD Workshop: Ertz, Preu • March 2008 Slide 5
National GLPInspectors
The GLP cascade
OECD Serieson GLP
National GLPlegislation
etc…
National GLPMonitoringAuthorities
EPA COFRAC AFSSAPSBerlin
16 FederalAgencies
BavariaFDAMAFF
AFSSA
OECD Workshop: Ertz, Preu • March 2008 Slide 6
制度GLP
GLP
GLPGLPGLPGLPGLP
Worldwide GLP - the devil is in the detail…
This creates issues for test facilities operating on an internatThis creates issues for test facilities operating on an international levelional level
BPL BPL
OECD Workshop: Ertz, Preu • March 2008 Slide 7
A worst-case studyAn international multi-site study
PI USA
PI Brazil
PI Japan
PrincipalInvestigators (PIs)
PI SpainPI FrancePI BelgiumPI Greece
Study Director (SD)Germany
OECD Workshop: Ertz, Preu • March 2008 Slide 8
A worst-case studyApproval of the study plan
Belgium 03/GLP Manual/E:The study plan needs to be approved in addition by:
the sponsortest site management
The study plan is approved by:the study directortest facility managementthe principal investigators
OECD Workshop: Ertz, Preu • March 2008 Slide 9
A worst-case studyCharacterization of Test Item
MAFF: The certificate of the test item must be prepared under GLP.
EPA: The certificate of the test item must be prepared under GLP or GMP.
OECD: The characterization of the test item does not need to be prepared under GLP.
OECD Workshop: Ertz, Preu • March 2008 Slide 10
A worst-case studyAssigning QA responsibility
A Lead QA Unit is assigned.OECD No 13, French version: One individualQA person must be assigned as Lead QA.
MAFF: The QA manager must appoint QA auditors per study.
OECD Workshop: Ertz, Preu • March 2008 Slide 11
A worst-case studyAmendments to the study plan
Belgium 03/GLP Manual/E:Each amendment to the study plan needs to be approved in addition by:
• the sponsor• test facility management
Amendments are approved by the study director. In special cases also by test facility management.
OECD Workshop: Ertz, Preu • March 2008 Slide 12
A worst-case studyDeviations from the study plan
NIT DICLA 035:Amendments and deviations should be maintained with the study plan.
Deviations should be maintained with the raw data.
MAFF: Deviations which have no impact on the quality of the study do not need to be described.
OECD Workshop: Ertz, Preu • March 2008 Slide 13
A worst-case studyPreparation of the final report
The Statement of GLP Compliance (SOC) quotes:
the OECD Series on GLPand the National Guidelines of the Test Facility (in this case Germany).
The rest is covered by the MAD agreement.
The SOC also needs to quote the Japanese GLP guidelines if the study is submitted in Japan.
The SOC also needs to quote the EPA GLP guidelines if the study is submitted in the USA.
OECD Workshop: Ertz, Preu • March 2008 Slide 14
A worst-case studyPreparation of the final report - continued
The Statement of GLP Compliance (SOC) is signed by the study director.
Inspection comment……it is not acceptable that the SOC is also signed by the sponsor…
EPA: …it must also be signed by the sponsor and the applicant submitting the study.
OECD Workshop: Ertz, Preu • March 2008 Slide 15
A worst-case studyPreparation of the final report - continued
If I am on holiday, and the final report needs to be finalized urgently, my appointed deputy study director (SD) can sign the final report .
Inspector comment:…it is not acceptable that the deputy SD signs the final report, as he/she was not involved in detail in the study….
…but of course the deputy SD can assign himself as SD in an amendment and then sign the final report….