This presentation is about USFDA GLP & other types of GLP . IT also have examples of warning letter that are part of Data Integrity

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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
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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
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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 .
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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
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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
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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
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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
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Data Integrity &
Failure of Quality Assurance to Report to Management

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Test Item Control Office Failed maintain Utilization Records

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Management Failed to Replace Study Director

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Unforeseen Circumstances were not addressed by
Study Director

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Lack Of Documentation

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Draft SOPs in Laboratory

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Procedures Not Defined For Animal Care

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Study Director Failed include all the Information
in the Final Report .

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Study Director Failed include all the Information
in the Final Report .

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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.

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