Inspections, Compliance, Enforcement, and Criminal Investigations

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 AgencyÂ’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

Page Last Updated: 04/15/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.