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(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

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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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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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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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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

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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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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

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.

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