Compliance Program
Guidance Manual
for FDA Staff

Updated: 06/03/2003

Compliance programs available in electronic form on FDA websites:

• Biologics (Chapters 42 - 45)

• Bioresearch Monitoring (BIMO)  (Chapter 48)

• Drugs (Chapters 53 - 56)

• Devices/Radiological Health (Chapters 81 - 86)

• Food and Cosmetics (link to CFSAN documents)

Page content updated: 06/03/2003 (tc)

Biologics

CPGM (HTML)	Compliance Program Description	Formats Available
7341.002	Inspections of Tissue Establishments	Read online PDF version
7342.002	Inspection of Source Plasma Establishments	Read online
7342.006	Inspections of Plasma Derivatives of Human Origin	Read online PDF version
7342.008	Inspections of Licensed Viral Marker Test Kits	Read online PDF version
7345.001	Inspections of Licensed Allergenic Products	Read online PDF version Looking for more exclusive Biotech Information? In addition to our free knowledge base, BiotechWatch provides the following additional services: Premium Database, for in-depth coverage of biotechnology companies in the sector, giving the user the ability to search and sort based on more than twenty parameters. TrialView Database, which offers disease-specific and biotechnology sector-wide clinical trial information. Make your View Count - at BiotechWatch's You Too Can Be An Analyst. Vote on the success of upcoming biotech events. Visit the Biotech Forum, where you can exchange ideas and generate new biotech investments.
7345.002	Inspections of Licensed Vaccines	Read online

BIMO: Bioresearch Monitoring

7348.001	In Vivo Bioequivalence	PDF version 78KB
7348.808	Good Laboratory Practice (Non-Clinical Laboratories)	Read online PDF version 117KB
7348.808A	Good Laboratory Practice (EPA Data Audit Inspections)	PDF version 31KB
7348.809 (HTML not available)	Institutional Review Boards	PDF version 1.05MB
7348.810	Sponsors, Contract Research Organizations and Monitors	Read online PDF version 1.84mb
7348.811	Clinical Investigators	Read online PDF version 3.24mb

Drugs

7353.001	Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations	Read online PDF n/a
7356.002	Drug Manufacturing Inspections (Effective 02/01/2002)	PDF version MS Word

Devices/Radiological Health

CPGM 7382.845	Inspections of Medical Device Manufacturers Read online: Description cover_page     part1     part2     part3     part4     part5     part6     xref_Index     oc_organization_chart (readable but format lost)
	Download MS Word Format:    Size Description    54784 cover_page.doc    37376 part1.doc    49664 part2.doc    84480 part3.doc    35840 part4.doc    73728 part5.doc    85504 part6.doc    63488 xref_Index.doc    27136 ocorgan.doc	Download PDF Format: Size 327KB 7382_845.pdf
	CPGM 7382.845 Attachments   Read online:    Description    Att_A.htm    Att_B.htm    Att_B-1.htm    Att_C.htm    Att_D.pdf ->    Att_E.htm    Att_F.htm    Att_G.htm
	Download MS Word Format:    Size     Description    63488 Att_A.doc    76288 Att_B.doc    29184 Att_B-1.doc    45568 Att_C.doc      9620 7382_845_Att_D.pdf ->    59904 Att_E.doc    41472 Att_F.doc    32256 Att_G.doc	Download PDF Format: Size 9620 Att_D.pdf
7386.002	Compliance Program Guidance Manual: Field Implementation of the Sunlamp and Sunlamp Product Performance Standard, as amended; (CP 7386.002); Final Guidance for Industry and FDA Posted: 11/30/2001 Looking for more exclusive Biotech Information? In addition to our free knowledge base, BiotechWatch provides the following additional services: Premium Database, for in-depth coverage of biotechnology companies in the sector, giving the user the ability to search and sort based on more than twenty parameters. TrialView Database, which offers disease-specific and biotechnology sector-wide clinical trial information. Make your View Count - at BiotechWatch's You Too Can Be An Analyst. Vote on the success of upcoming biotech events. Visit the Biotech Forum, where you can exchange ideas and generate new biotech investments.	Read online PDF version (CDRH documents)
7386.003 (HTML not available)	Field Compliance Testing of Diagnostic (Medical) X-ray Equipment Compliance Program	PDF version 76KB MS Word 143KB
	CPGM 7386.003 Attachments Attachments A-C Attachment D Attachment E Attachment F Attachment G Attachments H-K Attachment L Attachment M	PDF A-C D E F G H-K L M	MS Word A-C D E F G H-K L M
7386.004	Compliance Program for Field Compliance Testing of Cabinet X-ray Equipment (CP 7386.004); Final Guidance for Industry and FDA Staff Posted: 11/30/2001	Read online PDF version Looking for more exclusive Biotech Information? In addition to our free knowledge base, BiotechWatch provides the following additional services: Premium Database, for in-depth coverage of biotechnology companies in the sector, giving the user the ability to search and sort based on more than twenty parameters. TrialView Database, which offers disease-specific and biotechnology sector-wide clinical trial information. Make your View Count - at BiotechWatch's You Too Can Be An Analyst. Vote on the success of upcoming biotech events. Visit the Biotech Forum, where you can exchange ideas and generate new biotech investments. (CDRH documents)

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