Asia Pesticide Residue Mitigation through the Promotion of Biopesticides and Enhancement of Trade Opportunities (APRMP), Virtual lab meeting 12 August 2020

1. GLP TRAINING
 Wayne Jiang, PhD
IR-4, Michigan State University, jiangwa@msu.edu
 Michael Braverman, PhD
IR-4 Headquarters, Rutgers University
Sample Receipt,
Handling, and Storage

2. Review
• Protocol
• SOP
• Reference method
• Working method
• Routine/non-routine
• Communication with SD
• LLMV / LOQ / MV
• Testing facility inspection
• Compliance statement
• Sample storage

3. Q & A
Which of the following requirements is NOT
true for a laboratory Standard Operating
Procedures to comply with GLP?
(A) Approved by TFM
(B) Immediately accessible
(C) Periodically reviewed
(D) Describing QA inspection
(E) Performing non-routine maintenance

4. Q & A
Experimental termination date means :
(A) The date on which last data is collected from
the study
(B) The date when SD signs the final report
(C) The date when the archiving is completed
(D) The date when the last sample are disposed
(E) The date when the ASR is signed.

5. Q & A
Study Completion date means :
(A) The date on which last data is collected from
the study
(B) The date when SD signs the final report
(C) The date when the archiving is completed
(D) The date when the last sample are disposed
(E) The date when the ASR is signed.

6. Q & A
Which studies require Good Laboratory
Practice (GLP)? Select all correct answers.
(A) Pesticide registration
(B) PFAS contaminant monitoring
(C) Food additives
(D) Food product marketing
(E) Nonclinical safety studies of development of
drugs

7. Sample Shipping
• Frozen samples are shipped from field sites to
the Laboratory
• Samples are placed in a proper container
(plastic ice chest better)
• With appropriate temperature monitoring
• If shipped with dry ice, recommended ratio is
Sample : dry ice = 1:4
(by weight)

8. Sample Shipping Carriers
ACDS
Freezer Truck
Package
Carrier
Services

9. Sample Receipt
In the Laboratory:
• Sample conditions are checked upon receipt.
• Samples identified with shipping form/protocol
and logged in.
• Unique lab numbers are cross referenced to
field sample numbers.

10. Example: IR-4 Form 8B
IR-4 Field Data Book
Part 8 Residue Sample Shipping
B. Residue Sample Chain of Custody Form

11. IR-4 Form 8B
Trial Info
FRD
Lab unique
Sample ID
Sign.
Date
Check these boxes

12. Conditions of Samples

13. • After grinding, place samples
in a freezer (shor-term)
• After dry ice sublimed, transfer
samples to a walk-in freezer
(long term)
•Record the movements
•Montor the freezer temperatures
Short-Term Storage
-20°C
Standalone
Freezer

14. Long Term Storage
-20°C
Walk-in
Freezer

15. Walk-in Freezer Alarm System
Audio
Alarm
Phone
Dialer
Notes &
Emergency
Contacts

16. Monitoring Systems
Web
System
DOS
System
Live
Demonstration
• Phone
• Web

17. Hobart Food Chopper

18. Food Processors
Robot Coupe

19. Robot Coupe
(size 10 Liters)
Robot Coupe

20. Wiley Mill
Wiley Mill

21. Grinding Samples with Dry Ice

22. Grinding Samples

23. Ground Sample

24. Ground Sample
By Robot Coupe

25. Mixing multi
batches of
ground sample

26. Large sized
Grinder

27. Shredding sample
before grinding
Shredder

28. Shredded
sample

29. Grinding
Shredded
sample

30. Ground
sample

34. Reference Substance
• Section 28 in an IR-4 protocol describes how to
obtain reference substance and the contact
information.

35. GLP
compliance
Name, Lot #, storage,
purity, exp. date
Lab unique ID,
date received, initial
True copy
of COA

36. COA (Re-certification)
Same
Lot #
Original COA Re-Certification
Extended
exp. date
Same lab
unique IDexp. Date
(original)

37. Standard Form - Part 2
• For standard solution
only
- Analytical Reference Standard
Record and Use Log – Part 2.
- The % purity of the reference
standard is taken into account
when the stock solution
concentration is calculated.

38. Standard Solution Labels
• All containers of reagents
and solutions must be
labeled correctly including
chemical name,
concentration, solvent (when
used), preparation, and
expiration dates as well as
storage conditions.
• Handwriting is also
acceptable as long as all
information is included and
they are legible.

39. Reagents & Solutions
For standard, reagents, and solvents:
• Be Kept in original bottles (with exp. date)
For all solutions:
• Add adequate labeling, including
– Identity
– Concentration
– Solvent
– Storage requirements
– Expiration date
– Prepared by and prep date

40. Reagents & Solutions

41. Q & A
Which of the following requirements is NOT true for
a laboratory Standard Operating Procedures to
comply with GLP?
(A) Approved by TFM
(B) Immediately accessible
(C) Periodically reviewed
(D) Describing QA inspection
(E) Performing non-routine maintenance

42. Q & A
Experimental termination date means :
(A) The date on which last data is collected from
the study
(B) The date when SD signs the final report
(C) The date when the archiving is completed
(D) The date when the last sample are disposed
(E) The date when the ASR is signed.

43. Q & A
Study Completion date means :
(A) The date on which last data is collected from
the study
(B) The date when SD signs the final report
(C) The date when the archiving is completed
(D) The date when the last sample are disposed
(E) The date when the ASR is signed.

44. Q & A
Which studies require Good Laboratory
Practice (GLP)? Select all correct answers.
(A) Pesticide registration
(B) PFAS contaminant monitoring
(C) Food additives
(D) Food product marketing
(E) Nonclinical safety studies of development of
drugs

45. jiangwa@msu.edu

46. Form QA4 Revised effective 1/31/10 SOP 8.6 Rev.5 App. A
A) Study Title:____________________________________________________________
Lab I.D. Number_______________________________________________________
*Phase of the study reviewed: ____________________________________________
Inspection Date: ________________________________________________________
B) Laboratory Research Director:
Name:_________________________________________________________________
Address:_______________________________________________________________
Phone: ( )__________________________________________________________
E-mail: _______________________________________________________________
C) Regional / ARS Laboratory Research Coordinator:
Name:_________________________________________________________________
Address:_______________________________________________________________
Phone: ( )__________________________________________________________
E-mail: _______________________________________________________________
D) Quality Assurance Inspector:
Name:_________________________________________________________________
Address:_______________________________________________________________
Phone: ( )__________________________________________________________
E-mail: _______________________________________________________________
E) Study Director:________________________________________________________
E-mail: _______________________________________________________________
F) Test Site Location:______________________________________________________
______________________________________________________________________
______________________________________________________________________
G) Please fill out the following checklist.
Provide a narrative on any items marked No and provide suggestions and
recommended actions to be taken as appropriate for all QA findings. Use
additional forms if needed. Study personnel must respond to QA Findings.
Please Note:
Any problems which are likely to affect the study’s integrity found during the course of the
review must be brought to the attention of the Study Director/Testing Facility Management at
IR-4 HQ immediately.
*Phase of the study is very important:
Please indicate on the line provided. Each study must have at least one phase inspection. Use
one QA review form per phase per study.
IR-4 PROJECT
Analytical In-Life Inspection
□ Circulate to TFM/SD simultaneously
Page 1 of -----
_________

47. Form QA4 Revised effective 1/31/10 SOP 8.6 Rev.5 App. A
Page 2 of ____
Analytical In-Life Inspections
ID #_________________
A. General YES NO N/A
* 1. Protocol and method available to appropriate personnel.
* 2. Discovered changes/revisions of approved protocol documented
* 3. Procedures, as listed in the protocol, being followed
* 4. Modifications to the validated method documented and approved
by the LRD and Study Director
* 5. Lab operations relating to study conducted according to SOPs.
* 6. SOPs available to lab personnel.
* 7. SOP deviations documented in raw data.
* 8. SOP deviations approved by the Study Director
* 9. Adequate number of trained personnel.
* 10. Observed procedures relating to study.
*11. Observed procedures conducted for protocol.
* Minimal GLP requirements associated with Series 860.
N/A=Not Applicable
Comments

48. Form QA4 Revised effective 1/31/10 SOP 8.6 Rev.5 App. A
Page 3 of ____
Analytical In-Life Inspections
ID #____________________
B. Equipment / Instrument YES NO N/A
*12. Equipment calibrated / standardized.
*13. Equipment cleaning / maintenance is documented.
*14. Logbooks up-to-date.
*15. SOP for equipment in place and current.
C. Samples YES NO N/A
*16. Sample is uniquely identified according to:
a. Protocol.
b. SOP.
*17. Sample ID appears on container.
*18. Sample container is identified by:
a. Test system.
b. Field I.D. Number
c. Nature of the sample
d. Date of collection / site.
e. Test substance.
*19. Samples are maintained under proper storage.
a. Sample storage located documented.
b. Temperature and maintenance records up-to-date.
*20. Sample preparation (i.e. processing, extraction, analysis, etc.) is
properly recorded.
*22. Sub samples properly identified during
a. Processing.
b. Weighing.
*22. Sample integrity maintained during preparation.
* Minimal GLP requirements associated with Series 860.
N/A=Not Applicable
Comments

49. Form QA4 Revised effective 1/31/10 SOP 8.6 Rev.5 App. A
Page 4 of ____
Analytical In-Life Inspections
ID #________________
D. Reagents, Solvents, and Solutions YES NO N/A
*23. Reagents, Solutions, Solvents are labeled:
a. Identity / concentration / storage requirements.
b. Expiration date
*24. Standard Solutions:
a. Have been prepared according to SOP/method.
b. Have been properly labeled.
I. Identity / concentration.
ii. Date prepared / prepared by (if applicable).
iii. Storage conditions / expiration date.
c. Are not out-of-date.
d. Are properly stored.
E. Recording of Data YES NO N/A
*25. Hand generated data are properly recorded.
a. Directly, promptly, legibly.
b. In indelible ink.
c. On an appropriate form or in lab raw data.
*26. Entries are dated and initialed appropriately.
*27. Analytical standards used are properly identified in raw data.
*28. Changes to raw data. Do not obscure the original entry.
a. Explained.
b. Dated.
c. Initialed.
*29. Computer generated data.
a. Program has been validated.
b. Input personnel identified.
c. Data calculation verified.
*30. Lab raw data stored according to SOP.
* Minimal GLP requirements associated with Series 860.
N/A=Not Applicable
Comments

50. Form QA4 Revised effective 1/31/10 SOP 8.6 Rev.5 App. A
Page _______ of ______
Study Title:
Study No.:___________________________ Study Dir.:
Findings/Actions
QA Findings Response/Actions Taken*
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
______________________________ ______________________________
____________________________________ ____________________________________
Quality Assurance Date Responder** Date
* - Place responses/ explanation of corrective action in space provided to the right side of the findings or
use a separate sheet of paper.
** Responder(s) are to assure they have identified themselves either by signing the bottom of this page
or by initialing and dating the written response(s).

51. Form QA4 Revised effective 1/31/10 SOP 8.6 Rev.5 App. A
Page ______ of ______
Study Title:__________________________________________________________________
Study No.: _________________________________ Study Director:
Findings, Responses and Actions Taken*:
____________________________________ ____________________________________
Quality Assurance Date Responder** Date
* - Place responses/ explanation of corrective action in space provided between findings or use a
separate sheet of paper.
** Responder(s) are to assure they have identified themselves either by signing the bottom of this page
or by initialing and dating the written response(s).