epa regulatory update - glp quality...

2/13/2008 SQA Baltimore 1

SOCIETY OF QUALITY ASSURANCE REGULATORY FORUM

EPA REGULATORY UPDATE

Linthicum Heights, Maryland

January 24, 2008

Robert Cypher

United States Environmental Protection Agency


ANY UNITED STATES GLP FIELD TRIAL MAY

BE SUBMITTED TO OTHER COUNTRIES IN

THE WORLD


Toxicology7.3%

Field Sites36.5%

Chemistry12.5%

Product Chemistry22.9%

Antimicrobial4.2%

Insecticide12.5%

Others4.2%

35

12

22

12

4

Total Inspections 96Total data audits 304Human studies 11

FY2007 - INSPECTIONS BY DISCIPLINE

7

4


FIELD SITES INSPECTED - FY2007

• Total field sites inspected 35– IR-4 field sites 13 (37%)– Non IR-4 field sites 22 (63%)


FY2007 FIELD SITES INSPECTIONS

Total Inspections

Field Sites

Gov/Public/Academia

No. Inspections

In Compliance

Non-Gov/Private Sector

No. Inspections

In Compliance

0 20 40 60 80 100

(Inspector's Findings)

(Inspector's Findings)

96

92%

35

73%

13

1

22

16

12


COMPLIANCE PROFILE FY 2007High Level Violations

FIELD SITESTotal GLP Inspections 96

Inspections 35

In Compliance 34 (97%)


GLP COMPLIANCE RATE - FY2007

Field

Toxicology

Antimicr

obial

Analy C

hemist

ry

Insecti

cide E

ff

Prod C

hemist

ry

Others0

5

10

15

20

25

30

35

40

Inspections Compliance Rate (No findings) Compliance Rate (High Level Violations)

74%

83%

50%25%100%86%

97%

80%

75%58%100% 68%

100%100%

50%


Total Inspections Field Sites In Compliance In Compliance0

20

40

60

80

100

120Fy2004 FY2005 FY2006 FY2007

(No findings) (High level violations)

76

96102

96

16

30

38 35

1523

28 28

94% 77% 74% 80%

15

2934 34

94% 97% 89% 97%

FY2004-FY2007 COMPLIANCE STATISTICSFIELD SITES


Subpart ASubpart BSubpart CSubpart DSubpart ESubpart FSubpart GSubpart J

Science Issues

0

1

2

3

4

5

FY 2007 GLP VIOLATIONSFIELD SITES

0 0 44 1

9

3 0 0 3


GLP FIELD SITE VIOLATIONSBY CITATION FY2007

• Subpart B– Training records, experience and job

descriptions not available– Final report does not reflect raw data



• Subpart E– SOP deviations– Reagents were not labeled according to GLP– Experimental dates were determined arbitrarily



• Subpart G– Changes to protocol were not signed

by the Study Director– PI do not have a complete protocol– Activity and observations were not

recorded



• Subpart J– Test facility (Study Director) did not have a

copy of the final report– Final report does not reflect raw data


FY2007 STUDY REJECTIONS

• Product chemistry– Five (5) studies– One (1) laboratory


EPA INTERNATIONAL ACTIVITIESOECD – MUTUAL ACCEPTANCE OF DATA

(MAD)

Guidance document – Archives “Establishment and Control of Archives that Operate in Compliance with Principles of Good Laboratory Practice”

4 (India, Singapore, Brazil, Argentina)

Provisional members of MAD (non OECD members)

3 (South Africa, Slovenia, Israel)

Members of MAD (non OECD members)

27Full members of OECD MAD

EPAChair of OECD GLP Working Group


GUIDANCE DOCUMENTSRELEVANT TO FIELD RESEARCHERS

No. 1 The OECD Principles of GLP

No. 4 Quality Assurance and GLP

No. 5 Compliance of Laboratory Suppliers with GLP Principles

No. 6 The Application of the GLP Principles to Field Studies

No. 8 The Role and Responsibility of the Study Director in GLP Studies

No. 10 The Application of the Principles of GLP to Computerized Systems

No. 11 The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP

No. 13 The Application of the Principles of GLP to the Organization and Management of Multisite Studies

No. 15 Establishment and Control of Archives that Operate in Compliance with Principles of Good Laboratory Practice.


OECD – MUTUAL ACCEPTANCE OF DATAWHAT IS NEW?


THE W

ORLD ACCORDING TO GLPTHE W









ORLD ACCORDING TO GLP


Brazil India ChinaArgentina Singapore Taiwan

Turkey Malaysia


OECD ACTIVITIES

No revisions of OECD Principles of GLPNo changes of GLP affecting field research in the USField studies conducted according to EPA GLP in the US will be accepted for review in other OECD Member countriesChina*Turkey*Malaysia*Taiwan*Brazil*ArgentinaOther countries

* Have visited EPA


OECD FUTURE ACTIVITIES

1) OECD event with industry in April 2008 in Rome, NAICC participates

2) GLP inspectors training – Israel, September 20083) Evaluation of GLP compliance monitoring programs of

Members of MAD4) Evaluation of US EPA GLP program in 2010, FDA in

20095) Evaluation of India’s GLP program in February 2008


Foreign countries inquiring about GLP compliance status of US Field Sites and laboratories

If your facility has not been inspected for the discipline they are interested in, your study

will not be accepted by foreign countries


FUTURE ACTIVITIES

• Biotechnology studies• Nanotechnology • Human testing


Robert Cypher

U.S. Environmental Protection Agency

1200 Pennsylvania Ave., NW (2225A)

Washington, DC 20460

202.564.2514 Tel Fax 202.564.0029

[email protected]

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