[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.12]
[Page 249-250]
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
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
[[Page 250]]
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.
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