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