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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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BIORESEARCH MONITORING GOOD LABORATORY PRACTICE

 

BIORESEARCH MONITORING
GOOD LABORATORY PRACTICE
Compliance Program 7348.808
(Nonclinical Laboratories)
Date of Issuance: February  21, 2001
Guidance For FDA Staff

This document is intended to provide guidance. It represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

 

Cover Page
Part I Background
Part II Implementation
Part III Inspectional
Part IV Analytical
Part V Regulatory/Administrative
Part VI References and Program Contact
Part VII Headquarters' Responsibilities
Attachment A Computer Systems
Date of Issuance: 02/21/2001