The New Canadian GLP System

1
The New Canadian GLP System

• Fred Vaughn
• Vaughn Agricultural Research Services Ltd.

2
Good Laboratory Practices

• Initiated by Canadas
• Pest Management Regulatory Agency (PMRA)
• Effective October 1, 1999

3
Four Parts

• Types of studies
• Comparison to US
• Accreditation program
• Impact on Canadian pesticide research

4
Crop Residue Studies
5
Dislodgeable Foliar Residue (DFR) Studies
6
Transferable Turf Residues (TTR) Studies
7
Soil Dissipation Studies
8
Comparison to US
9
Efficacy under GLP?

• In the US Everything submitted must be
  compliant, including efficacy, however,
  efficacy generally is not submitted
• In Canada Efficacy is submitted, but is not
  specifically listed as work that must be
  under GLP

10
Canadian System Administered by the Standards
Council of Canada

• GLP Monitoring Authority (GLPMA)

11
Regulatory Authority

• PMRA Directive 98-01
• Section 4.2 If a compliance statement is not
  supported by a GLPMA recognition of the test
  facility, the PMRA may refuse to consider the
  study as reliable.

12
GLP System in the US

• Environmental Protection Agency (EPA) under
  FIFRA (40 CFR 160)
• EPA audits facilities and studies, but there is
  no formal recognition system for facilities
• Audits are random, or are based on specific
  concerns
• No charge for the audit

13
GLP System in Canada

• Organization for Economic Cooperation and
  Development (OECD)
• - UK, France, Germany, Italy, etc.
• - Canada
• Certification process
• Facilities become recognized as GLP-compliant

14
Accreditation Process

• Inspection
• Facility response
• SCC review of
• response
• Approval
• Certificate issued

15
Preparation for an SCC Audit

• SOPs must be of a high standard, including one on
  computer software validation
• Facility floor plan, organizational chart, job
  descriptions, CVs, training records, equipment
  logs and archives must be current and properly
  integrated
• Test substance and sample storage records
  prepared for inspection

16
Preparation for an SCC Audit

• Archives set up and organized for easy review
• Go over the SCC checklist
• Studies are audited. Raw data needs to be readily
  available and permission to review granted.
• Coffee pot at the ready

17
Accreditation

• Valid for three years from the date of issue
• Facility gets listed on the SCC web site
• Internationally recognized

18
Impact on Canadian Pesticide Research

• Positives
• Negatives

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More Calibration

• Calibration results are documented on all
  equipment
• Application equipment is calibrated prior to each
  use

20
More Documentation

• Test substance use log
• Chain of custody for all samples
• Logs kept on all equipment

21
More Monitoring

• Weather data
• Storage temperatures
• Personnel
• Adverse effects

22
System Validation

• Validation of rain gauges, probes, thermometers
• Software validation

23
Auditing

• Critical phase audits
• Raw data notebooks
• Facility audits (SCC)

24
Multi-site Studies
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Costs of GLP Compliance

• Standard
• An increased number of trained staff are needed
  to carry out all functions
• QA function required for each study
• Specialized equipment
• New
• Standards Council of Canada audit (4200 for VARS
  in 1999)

26
Cost Impact

• Residue program costs may lead to fewer new
  product introductions
• Cost of compliance may lead to some organizations
  choosing not to do compliant work

27
Reporting

• Protocols and reports will specify which GLP
  guidelines are being followed
• EPA, OECD, or both

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Reporting
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Key Positives

• Ensures studies are carried out to the highest
  quality standards
• Potential for fraud virtually eliminated
• Recognition for the facility and mutual
  acceptance of the data

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Key Negatives

• Costs
• GLP is sometimes deemed more important than the
  scientific aspects
• The time required for planning, conducting and
  reporting is greater

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Issues

• Costs
• Efficacy
• Minor use

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Conclusions

• A good system for ensuring quality is now in
  place
• Recognition of the facilities and mutual
  acceptance of the data will help the industry

33

• Thank you
• NAICC

Fred Vaughn Vaughn Agricultural Research Services
Ltd.