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January 28, 2017 Krish Research Biotech Pvt. Ltd 1
USFDA GLP (21 CFR PART 58)
&
DATA INTEGRITY
Anand .P
(anand_pandya@live.com)
Krish Biotech Research Pvt. Ltd
Types of GLP practised in USA
•40 CFR Part 792 : Good Laboratory
Practice Standards .
•40 CFR Part 160 : Good Laboratory
Practice Standards .
•21 CFR Part 58 : Good Laboratory
Practice for Non Clinical Laboratory
Studies
January 28, 2017 Krish Research Biotech Pvt. Ltd 2
40 CFR Part 792 : Good Laboratory
Practice Standards .
•Came In force by The Toxic Substances
Control Act .
•It Prevents entering toxic substances
into the Environment .
•It aims detection & determination of
toxicity
January 28, 2017 Krish Research Biotech Pvt. Ltd 3
40 CFR Part 160 : Good Laboratory
Practice Standards .
•Came In force by The Federal Insecticide
, Fungicide and rodenticide Act (FIFRA)
•It is directed towards detection of
Pesticide in the environment and the
determination of their effects on
Higher Organisms .
January 28, 2017 Krish Research Biotech Pvt. Ltd 4
21 CFR Part 58 : Good Laboratory
Practice for Non Clinical Laboratory
Studies
•The FDA GLP is concern with introduction
of pesticides and toxic substances from
environment into foods .
•FDA GLP easily deals with laboratory
requirements of 40 CFR Part 160 & 40 CFR
Part 792
January 28, 2017 Krish Research Biotech Pvt. Ltd 5
21 CFR PART 58
Subpart A: General Provisions
Subpart B: Organization/Personnel
Subpart C: Facilities
Subpart D: Equipment
Subpart E: Testing Facilities Operation
Subpart F: Test and Control Articles
Subpart G: Protocol for and Conduct of a
nonclinical Laboratory Study
Subpart J: Records and Reports
Subpart K: Disqualification of Testing Facilities
January 28, 2017 Krish Biotech Research Pvt. Ltd 6
Subpart A: General Provisions
Protocol: Approved, written document that
clearly indicates objectives, study design and
all methods to be used in conducting the
study
Test Article
Control Article: Any chemical substance or
mixture, analytical standard, or material, other
than a test substance, feed, or water,
administered to or used in analyzing the test
system to establish bases for comparison…
commonly referred to as positive control or an
analytical standard
January 28, 2017 Krish Biotech Research Pvt. Ltd 7
January 28, 2017 Krish Research Biotech Pvt. Ltd 8
Carrier: the material which is used for
administration to the test system or an agent
which facilitates the mixture, dispersion or
solubilization of a test substance with a carrier eg
adjuvants , Corn Oil , feed etc .
.
Data Integrity
& Warning letters for Non-Compliance
of
21CFR : Part 58
January 28, 2017 9
January 28, 2017 Krish Research Biotech Pvt. Ltd 10
January 28, 2017 Krish Research Biotech Pvt. Ltd 11
Data Integrity &
Failure of Quality Assurance to Report to Management
January 28, 2017 Krish Research Biotech Pvt. Ltd 12
Test Item Control Office Failed maintain Utilization Records
January 28, 2017 Krish Research Biotech Pvt. Ltd 13
Management Failed to Replace Study Director
January 28, 2017 Krish Research Biotech Pvt. Ltd 14
Unforeseen Circumstances were not addressed by
Study Director
January 28, 2017 Krish Research Biotech Pvt. Ltd 15
Lack Of Documentation
January 28, 2017 Krish Research Biotech Pvt. Ltd 16
January 28, 2017 Krish Research Biotech Pvt. Ltd 17
Draft SOPs in Laboratory
January 28, 2017 Krish Research Biotech Pvt. Ltd 18
January 28, 2017 Krish Research Biotech Pvt. Ltd 19
Procedures Not Defined For Animal Care
January 28, 2017 Krish Research Biotech Pvt. Ltd 20
Study Director Failed include all the Information
in the Final Report .
January 28, 2017 Krish Research Biotech Pvt. Ltd 21
January 28, 2017 Krish Research Biotech Pvt. Ltd 22
Study Director Failed include all the Information
in the Final Report .
January 28, 2017 Krish Research Biotech Pvt. Ltd 23
January 28, 2017 Krish Research Biotech Pvt. Ltd 24
January 28, 2017 Krish Research Biotech Pvt. Ltd 25
January 28, 2017 Krish Research Biotech Pvt. Ltd 26
Do’s and Don’ts
During An GLP Inspection
When dealing with the GLP- investigator,
we should demonstrate knowledge and
confidence in our quality system.
Not arrogant .…
The DO’s During an Inspection
* Never give false data, always tell the truth
* Is it OK to say “I don’t know”?
* The investigator may ask the same question to
different people at different times
The DON’Ts During an Inspection
If the investigator asks you for some
information, do not:
* make them ask for it again
* wait to see if they forget about the request
The DON’Ts During an Inspection
*It is not productive to argueargue with the investigator when
responding to a question or observation
*Don’t challengechallenge the investigator. There is no need for
that. It only motivates curiosity and questions.
The DON’Ts During an Inspection
*Do not stand around making faces and looking worried. This
makes people feel nervous and may alert the investigator that
something may be wrong.
*Act confident and proudconfident and proud, not defensive.
*If a fellow employee is being questioned, do not try to help them
by answering the questions yourself or by giving contradictory
information.
The DON’Ts During an Inspection
*Do not interrupt the investigator or other
employees when they are speaking
*Do not talk loud or speak with the others
when the investigator is trying to concentrate,
read or review documentation.
*It is not your job to fill an uncomfortable
silence with additional explanation.
The DON’Ts During an Inspection
The DON’Ts During an Inspection
Loose
lips
sink
ships!
Don’t talk – even off site!!!
Things To Remember
During An GLP Inspection
*If it isn’t documented, it
doesn’t exist
Things to Remember During an Audit
*Investigator may
“read” your body
language
*Be aware of your
body language
Things to Remember During an Audit
* Stick to the facts not opinions. Do not use phrases
such as:
I think …
I’m not sure but …
In my opinion, it should …
What you are saying is not true…
Honestly… Usually… Typically…
As I recall…
Things to Remember During an Audit
If you think that the investigator has misunderstood
something
*say so immediately
*explain why in a professional manner
Things to Remember During an Audit
Phrases to Refrain From!
* That’s the way we’ve always done it
* Off the record…
* I probably shouldn’t say this but…
* Who, me?
* … Uh, no
* It’s probably a mistake.
January 28, 2017 Krish Research Biotech Pvt. Ltd 41

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21 CFR Part 58 & Data integrity

  • 1. January 28, 2017 Krish Research Biotech Pvt. Ltd 1 USFDA GLP (21 CFR PART 58) & DATA INTEGRITY Anand .P (anand_pandya@live.com) Krish Biotech Research Pvt. Ltd
  • 2. Types of GLP practised in USA •40 CFR Part 792 : Good Laboratory Practice Standards . •40 CFR Part 160 : Good Laboratory Practice Standards . •21 CFR Part 58 : Good Laboratory Practice for Non Clinical Laboratory Studies January 28, 2017 Krish Research Biotech Pvt. Ltd 2
  • 3. 40 CFR Part 792 : Good Laboratory Practice Standards . •Came In force by The Toxic Substances Control Act . •It Prevents entering toxic substances into the Environment . •It aims detection & determination of toxicity January 28, 2017 Krish Research Biotech Pvt. Ltd 3
  • 4. 40 CFR Part 160 : Good Laboratory Practice Standards . •Came In force by The Federal Insecticide , Fungicide and rodenticide Act (FIFRA) •It is directed towards detection of Pesticide in the environment and the determination of their effects on Higher Organisms . January 28, 2017 Krish Research Biotech Pvt. Ltd 4
  • 5. 21 CFR Part 58 : Good Laboratory Practice for Non Clinical Laboratory Studies •The FDA GLP is concern with introduction of pesticides and toxic substances from environment into foods . •FDA GLP easily deals with laboratory requirements of 40 CFR Part 160 & 40 CFR Part 792 January 28, 2017 Krish Research Biotech Pvt. Ltd 5
  • 6. 21 CFR PART 58 Subpart A: General Provisions Subpart B: Organization/Personnel Subpart C: Facilities Subpart D: Equipment Subpart E: Testing Facilities Operation Subpart F: Test and Control Articles Subpart G: Protocol for and Conduct of a nonclinical Laboratory Study Subpart J: Records and Reports Subpart K: Disqualification of Testing Facilities January 28, 2017 Krish Biotech Research Pvt. Ltd 6
  • 7. Subpart A: General Provisions Protocol: Approved, written document that clearly indicates objectives, study design and all methods to be used in conducting the study Test Article Control Article: Any chemical substance or mixture, analytical standard, or material, other than a test substance, feed, or water, administered to or used in analyzing the test system to establish bases for comparison… commonly referred to as positive control or an analytical standard January 28, 2017 Krish Biotech Research Pvt. Ltd 7
  • 8. January 28, 2017 Krish Research Biotech Pvt. Ltd 8 Carrier: the material which is used for administration to the test system or an agent which facilitates the mixture, dispersion or solubilization of a test substance with a carrier eg adjuvants , Corn Oil , feed etc . .
  • 9. Data Integrity & Warning letters for Non-Compliance of 21CFR : Part 58 January 28, 2017 9
  • 10. January 28, 2017 Krish Research Biotech Pvt. Ltd 10
  • 11. January 28, 2017 Krish Research Biotech Pvt. Ltd 11 Data Integrity & Failure of Quality Assurance to Report to Management
  • 12. January 28, 2017 Krish Research Biotech Pvt. Ltd 12 Test Item Control Office Failed maintain Utilization Records
  • 13. January 28, 2017 Krish Research Biotech Pvt. Ltd 13 Management Failed to Replace Study Director
  • 14. January 28, 2017 Krish Research Biotech Pvt. Ltd 14 Unforeseen Circumstances were not addressed by Study Director
  • 15. January 28, 2017 Krish Research Biotech Pvt. Ltd 15 Lack Of Documentation
  • 16. January 28, 2017 Krish Research Biotech Pvt. Ltd 16
  • 17. January 28, 2017 Krish Research Biotech Pvt. Ltd 17 Draft SOPs in Laboratory
  • 18. January 28, 2017 Krish Research Biotech Pvt. Ltd 18
  • 19. January 28, 2017 Krish Research Biotech Pvt. Ltd 19 Procedures Not Defined For Animal Care
  • 20. January 28, 2017 Krish Research Biotech Pvt. Ltd 20 Study Director Failed include all the Information in the Final Report .
  • 21. January 28, 2017 Krish Research Biotech Pvt. Ltd 21
  • 22. January 28, 2017 Krish Research Biotech Pvt. Ltd 22 Study Director Failed include all the Information in the Final Report .
  • 23. January 28, 2017 Krish Research Biotech Pvt. Ltd 23
  • 24. January 28, 2017 Krish Research Biotech Pvt. Ltd 24
  • 25. January 28, 2017 Krish Research Biotech Pvt. Ltd 25
  • 26. January 28, 2017 Krish Research Biotech Pvt. Ltd 26
  • 27. Do’s and Don’ts During An GLP Inspection
  • 28. When dealing with the GLP- investigator, we should demonstrate knowledge and confidence in our quality system. Not arrogant .… The DO’s During an Inspection
  • 29. * Never give false data, always tell the truth * Is it OK to say “I don’t know”? * The investigator may ask the same question to different people at different times The DON’Ts During an Inspection
  • 30. If the investigator asks you for some information, do not: * make them ask for it again * wait to see if they forget about the request The DON’Ts During an Inspection
  • 31. *It is not productive to argueargue with the investigator when responding to a question or observation *Don’t challengechallenge the investigator. There is no need for that. It only motivates curiosity and questions. The DON’Ts During an Inspection
  • 32. *Do not stand around making faces and looking worried. This makes people feel nervous and may alert the investigator that something may be wrong. *Act confident and proudconfident and proud, not defensive. *If a fellow employee is being questioned, do not try to help them by answering the questions yourself or by giving contradictory information. The DON’Ts During an Inspection
  • 33. *Do not interrupt the investigator or other employees when they are speaking *Do not talk loud or speak with the others when the investigator is trying to concentrate, read or review documentation. *It is not your job to fill an uncomfortable silence with additional explanation. The DON’Ts During an Inspection
  • 34. The DON’Ts During an Inspection Loose lips sink ships! Don’t talk – even off site!!!
  • 35. Things To Remember During An GLP Inspection
  • 36. *If it isn’t documented, it doesn’t exist Things to Remember During an Audit
  • 37. *Investigator may “read” your body language *Be aware of your body language Things to Remember During an Audit
  • 38. * Stick to the facts not opinions. Do not use phrases such as: I think … I’m not sure but … In my opinion, it should … What you are saying is not true… Honestly… Usually… Typically… As I recall… Things to Remember During an Audit
  • 39. If you think that the investigator has misunderstood something *say so immediately *explain why in a professional manner Things to Remember During an Audit
  • 40. Phrases to Refrain From! * That’s the way we’ve always done it * Off the record… * I probably shouldn’t say this but… * Who, me? * … Uh, no * It’s probably a mistake.
  • 41. January 28, 2017 Krish Research Biotech Pvt. Ltd 41

Editor's Notes

  • #39: Truthful responses are direct. Deceptive responses use qualifiers and generalizations, or they blame memory. Responses Truthful subjects may use broad language – “I never falsified any data in any study” Deceptive subjects may use descriptive language – “I never falsified any CRF data in the HCV study”
  • #41: Truthful responses are direct. Deceptive responses tend to beat around the bush.