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Compliance Policy Guides (CPG) explain the Food and Drug Administration (FDA) policy on regulatory issues related to the FDA laws or regulations. These include Current Good Manufacturing Practice (CGMP) regulations and application commitments. They advise the field inspection and compliance staffs as to the Agency's standards and procedures to be applied when determining industry compliance. Compliance Policy Guides may derive from a request for an advisory opinion, from a petition from outside the Agency, or from a perceived need for a policy clarification by FDA personnel.
The field staff is continually encouraged to contact the Division of Compliance Policy (HFC-230) when they need clarification on an existing CPG or see a need for a new CPG. The Office of Enforcement is committed to providing the needed guidance.
The Compliance Policy Guides Manual was updated last year and published in a bound format. This is the second bound edition of the manual. It contains both revised and new Compliance Policy Guides. The index at the end of the manual identifies all forty CPGs that were revised and the two new CPGs (CPG 7150.19 and CPG 7125.40) issued since the last edition.
We received many constructive comments throughout the year to further improve the manual. All comments were welcomed and suggestions for improvements have been incorporated into this edition. We thank the people who took time to write or telephone. We extend the same offer for this edition. Please telephone or send your comments or suggestions for improvement to the Division of Compliance Policy (HFC-230), 5600 Fishers Lane, Rockville, MD 20857 (telephone number 301-827-0420). As usual, we appreciate all comments and suggestions for improvements.
| Daniel L. Michels, Director Office of Enforcement |
Arvin Shroff, PhD, Deputy Director Office of Enforcement |