[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.12]

[Page 255]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
   PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE 
PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents
 
     Subpart A--Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices
 
Sec. 26.12  Nature of recognition of inspection reports.

    (a) Inspection reports (containing information as established under 
Sec. 26.8), including a good manufacturing practice (GMP) compliance 
assessment, prepared by authorities listed as equivalent, will be 
provided to the authority of the importing party. Based on the 
determination of equivalence in light of the experience gained, these 
inspection reports will normally be endorsed by the authority of the 
importing party, except under specific and delineated circumstances. 
Examples of such circumstances include indications of material 
inconsistencies or inadequacies in an inspection report, quality defects 
identified in the postmarket surveillance or other specific evidence of 
serious concern in relation to product quality or consumer safety. In 
such cases, the authority of the importing party may request 
clarification from the authority of the exporting party which may lead 
to a request for reinspection. The authorities will endeavor to respond 
to requests for clarification in a timely manner.
    (b) Where divergence is not clarified in this process, an authority 
of the importing country may carry out an inspection of the production 
facility.