future issues including broadening the scope of the … · oecd event , villa tuscolana , frascati...

OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

FUTURE ISSUES INCLUDING BROADENING THE SCOPE OF THE GLP

PRINCIPLES

Francisca E. Liem

U.S. Environmental Protection Agency1200 Pennsylvania Ave, NW 2225A

Washington, DC 20460


MILESTONES OF THE GLPS

1982 OECD Principles of GLP

1997 OECD Principles of GLP (Revised)

OECD


ELECTRONIC DATA AND RECORD KEEPING


OECD GUIDANCE DOCUMENT NO. 10

The Application of the OECD Principles of GLP to Computerized Systems


U.S. ENVIRONMENTAL PROTECTION AGENCY

Cross Media Electronic Reporting and Record Keeping Rule

CROMERRRAugust 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 (C ross Media Electronic Rule – CROMERR)


UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA)

21 CFR Part 11


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


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)


INDUSTRIAL CHEMICALS

� Existing chemicals� Europe – REACH� USA – Test Rule

� New chemicals� Europe - REACH� USA – Consent Testing Agreement

� Fuel additives� Nanotechnology


OTHER GLP COMPLIANCE ISSUES

• Registration dossier– Cited old data (prior 1982)

– Cited scientific papers/publications

– Data developed in non-GLP countries

– Human testing


ARE WE READY?


MUTUAL ACCEPTANCE OF DATA (MAD)

• Global economy

• Reliance on other countries’ developed data

– Laboratory studies

– Field studies


MUTUAL ACCEPTANCE OF DATAOECD COUNCIL ACTS ON MAD

• 1981 Council decision on MAD in the Assessment of Chemicals

• 1989 Council decision/recommendation on Compliance with Principles of GLP

• 1997 Council decision on Adherence of Non-member Countries to the Council Acts to MAD


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


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)


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


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?


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


IN SPITE OF CHALLENGES TO

MONITORING AUTHORITIES

We have come a long way since 1981


THE WORLD ACCORDING TO GLPTHE W

ORLD ACCORDING TO GLPTHE W








ORLD ACCORDING TO GLP


Brazil India China

Argentina Chinese Taipei Singapore

Turkey Thailand Malaysia


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

SOPs


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


ARE WE READY?


Francisca E. LiemU.S. Environmental Protection Agency

1200 Pennsylvania Ave. NW 2225A

Washington, DC 20460

202.564.2365 tel fax 202.564.0029

[email protected]

future issues including broadening the scope of the … · oecd event , villa tuscolana , frascati...

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