FUTURE ISSUES INCLUDING
BROADENING THE SCOPE OF THE GLP
PRINCIPLES
Francisca E. Liem
U.S. Environmental Protection Agency
1200 Pennsylvania Ave, NW 2225A
Washington, DC 20460
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
MILESTONES OF THE GLPS
OECD
1982 OECD Principles of GLP
1997 OECD Principles of GLP (Revised)
OECD Event,
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ELECTRONIC DATA AND
RECORD KEEPING
OECD Event,
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OECD GUIDANCE DOCUMENT NO. 10
The Application of the OECD Principles of
GLP to Computerized Systems
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U.S. ENVIRONMENTAL
PROTECTION AGENCY
Cross Media Electronic Reporting and
Record Keeping Rule
CROMERRR
August 31, 2001 – Draft rules on Electronic Reporting and Record
Keeping (Cross Media Electronic Reporting and Record
Keeping Rule - CROMERRR)
October 13, 2005 – Final rule on Electronic Reporting (Cross Media
Electronic Rule – CROMERR)
OECD Event,
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Italy, April 10 – 11, 2008
UNITED STATES FOOD AND
DRUG ADMINISTRATION (FDA)
21 CFR Part 11
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UNITED STATES OF AMERICA
FEDERAL INFORMATION PROCESSING STANDARDS
(FIPS)
• FIPS 186-2 – Jan 2002 – Digital Signature Standard
• FIPS 186-3 – Mar 2006 – Digital Signature Standard
(Draft)
• FIPS 186-3 – Dec 2007 – RSA Strong Primes –
Digital Signature Standard (Draft)
• FIPS 190 – Guideline for the Use of Advanced
Authentication Technology Alternatives
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
NON-CONVENTIAL PESTICIDE PRODUCTS
REGISTRATION REQUIREMENTS
• Biological/microbiological pesticides
• Biocides
• Public health pesticides
– Insecticides
– Rodenticides
– Avicides
• Biotechnology
– Genetically Modified Organisms (GMO)
– Plant Incorporated Protectants (PIP)
OECD Event,
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Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
INDUSTRIAL CHEMICALS
Existing chemicals
Europe – REACH
USA – Test Rule
New chemicals
Europe - REACH
USA – Consent Testing Agreement
Fuel additives
Nanotechnology
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
OTHER GLP COMPLIANCE ISSUES
• Registration dossier
–
–
–
–
Cited old data (prior 1982)
Cited scientific papers/publications
Data developed in non-GLP countries
Human testing
OECD Event,
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Italy, April 10 – 11, 2008
ARE WE READY?
OECD Event,
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MUTUAL ACCEPTANCE OF DATA (MAD)
• Global economy
• Reliance on other countries’ developed data
– Laboratory studies
– Field studies
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
MUTUAL ACCEPTANCE OF DATA
OECD COUNCIL ACTS ON MAD
• 1981
• 1989
• 1997
Council decision on MAD in the
Assessment of Chemicals
Council decision/recommendation
on Compliance with Principles of
GLP
Council decision on Adherence of
Non-member Countries to the
Council Acts to MAD
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
MAD – NON OECD MEMBERS
• Welcome and encourage
• Recognized and accepted by OECD members
• Challenges:
– Small programs
– Small number of test facilities
– Experience
• Collaboration with major programs
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
OTHER CHALLENGES FOR GLP
MONITORING AUTHORITIES
• More trust in test facilities that have been inspected
– Slow down, less vigilant?
• May result in data quality and integrity problems as <1981
• Do more with less resources
– Change approach by MA
• Calendar based inspections
• Risk based inspections
– More facility inspections, less data audits
– Out-source inspections (Third Party)
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
MONITORING AUTHORITY MORE
VIGILANT INSTEAD OF LESS
• Initiate inspection program of new types of products
(non-conventional pesticide/chemical products)
• Train compliance and enforcement workers
– Science of the study
– Inspections of new types of product
• Change of workforce
– Backfill
– Expand workforce
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
INTERNATIONAL CHALLENGES FOR
OECD MEMBERS
• Harmonization of inspections of new types
of products
• Harmonization of application of Principles
• Dissemination of new procedures/policies
to the regulated community
• More resources needed
– Financial
– Human
• More flexible?
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
INTERNATIONAL CHALLENGES FOR
OECD MAD MEMBERS
• More reliance on other countries Monitoring
Authorities
• More communication needed between and among
MAD members
• OECD countries that do not have an official GLP
Monitoring program
• Registration requirements are not yet harmonized
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
IN SPITE OF
CHALLENGES TO
MONITORING
AUTHORITIES
We have come
a long way
since 1981
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
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OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
Brazil
India
China
Argentina
Chinese Taipei
Singapore
Turkey
Thailand
Malaysia
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
IN SPITE OF CHALLENGES TO
MONITORING AUTHORITIES
• We have come a long way since 1981
– Better quality of data
– Better quality of final reports
– Reconstruction of data
– Better data integrity
• Harmonization of GLP Monitoring programs
• Harmonization of GLP inspections and study audits
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
SOP
s
SUMMARY
• Technology keeps updating itself
• Non conventional products to be tested and
registered
• Old data and scientific papers
• MAD, new Non Members
• Other challenges for the future
– Compliance monitoring programs
– Compliance monitoring authorities
– International harmonization
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
ARE WE READY?
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008
Francisca E. Liem
U.S. Environmental Protection Agency
1200 Pennsylvania Ave. NW 2225A
Washington, DC 20460
202.564.2365 tel
fax 202.564.0029
Liem.francisca@epa.gov
OECD Event,
Event, Villa Tuscolana,
Tuscolana, Frascati (Roma), Italy,
Italy, April 10 – 11, 2008