21 cfr part 58 & data integrity

May 1, 2023 Krish Research Biotech Pvt. Ltd 1

USFDA GLP (21 CFR PART 58) &

DATA INTEGRITY

Anand .P([email protected])

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


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


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 .


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


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 FacilitiesMay 1, 2023 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

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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 .

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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


Test Item Control Office Failed maintain Utilization Records


Management Failed to Replace Study Director


Unforeseen Circumstances were not addressed by Study Director


Lack Of Documentation


Draft SOPs in Laboratory


Procedures Not Defined For Animal Care


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

Do’s and Don’tsDuring 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


*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.


*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.


* 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.



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


* 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…


If you think that the investigator has misunderstood something

*say so immediately

*explain why in a professional manner


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.

21 cfr part 58 & data integrity

Health & Medicine