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                FDA Bioresearch Monitoring Information

FDA Bioresearch Monitoring Information

                        Bioresearch Monitoring Program Information Home
          Inspections, Compliance, Enforcement, and Criminal Investigations
          Compliance Actions and Activities
          FDA Bioresearch Monitoring Information
          Compliance Program Guidance ManualFDA Bioresearch Monitoring Information Compliance Program Guidance Manual
  
  	
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            Compliance Program Guidance Manual**
**PROGRAM7348.808**

			
           
            Chapter 48
            Bioresearch Monitoring
            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.***
           Subject
           Good Laboratory Practice
            (Nonclinical Laboratories)
Implementation DateFebruary 21, 2001Completion DateContinuing
			
            Data ReportingPRODUCT CODES
            PRODUCT/ASSIGNMENT CODES51Z OR 52Z
                        04808 Chemical Contaminants (EPA)45Z, 46Z
                        09808 Food Additives57Z, 99Z
                        41808 Biologics (Therapeutics)
                        42808 Biologics (Blood)
                        45808 Biologics (Vaccines)60Z, 61Z
                        48808 Human Drugs68Z, 69Z
                        68808 Animal Drugs73Z, 74Z
                        94Z OR 95Z
                        83808 Medical and Radiological Devices
           Field Reporting Requirements
            All establishment inspection reports (EIRs), complete with attachments, exhibits, and any post-inspectional correspondence are to be **submitted** promptly to the assigning Center. If an EIR contains serious findings raising the possibility of one or more violations of the Federal Food Drug & Cosmetic Act (FFDCA) or other Federal statutes, a copy of the EIR should be forwarded to the District Compliance Branch at the time it is sent to the Center. If an FDA-483 is issued, a copy will be faxed to the Center contact identified in the assignment.
            If the district becomes aware of any significant adverse inspectional, analytical, or other information which may affect the agency's new product approval decisions with respect to a firm, the district should immediately notify the responsible Center program office via electronic mail, fax, or by phone.
            If samples are collected for analysis, the analyzing laboratory will **submit** copies of the Collection Report and the Analytical Work sheets to the District Office and the assigning Center.
            Hypertext updated April 3, 2001 tmc

                                                                                  Content current as of:
      04/08/2015FDA Bioresearch Monitoring Information

          
                        Bioresearch Monitoring Program Information
 
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