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Translation of Good Laboratory Practice Study Reports: Questions and Answers

DraftCenter for Drug Evaluation and Research11/21/2023
Good Laboratory Practice

Description

This FDA guidance provides information to sponsors and nonclinical laboratories regarding the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations (21 CFR part 58) submitted to FDA for review.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3
device safety studies

Type of GLP study received by FDA Centers.

safety pharmacology studies

Type of GLP study received by FDA Centers.

nonclinical toxicology studies

Type of GLP study received by FDA Centers.

Stakeholders

5
testing facility management

Management role whose typed name must appear in the translated report

quality assurance auditor

Role whose typed name must appear in the translated report

study director

personnel required to sign biological study reports

translator

Person with education, training, and experience in English and the original language

sponsor

responsible for justifying omission of studies

Regulatory Context

Regulatory Activities

2
marketing authorizations

Submissions to FDA supported by study reports

marketing authorization

Submissions to FDA to support the sale of products.

Document Types

5
written procedures

Required documentation for supplier approval and verification.

certificate

Alternative to a translation statement

translation statement

A signed and dated document attesting to the accuracy of the translation

GLP study report

The report generated from a GLP study

study report

Document describing procedures followed and samples retained

Technical Details

Processes

1
language translation

The process of converting study reports from a non-English language into English.

View on FDA.govDownload PDF

Related CFR Sections (2)

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure of the study director to assure protocol compliance and accurate data recording
1
Failure of the study director to assure experimental data are accurately recorded and verified
1
Failure to properly identify specimens
1
Failure to assure experimental data were accurately recorded and verified
1
Failure to authorize and document deviations from standard operating procedures
1
QAU failed to assure reported results accurately reflect raw data
1
Failure to maintain a Quality Assurance Unit
1
Study director failed to assure protocol compliance and data accuracy
1
Fabrication of animal weight data
1
Failure to establish procedures for handling test and control articles
1

Recent Cases

Related Warning Letters (9)

See Also (8)

Translation of Good Laboratory Practice Study Reports: Questions and Answers | Guideline Explorer | BioRegHub