[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: 21CFR26.9]
[Page 249]
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. 26.9 Equivalence determination.
(a) Equivalence is established by having in place regulatory systems
covering the criteria referred to in Appendix D of this subpart, and a
demonstrated pattern of consistent performance in accordance with these
criteria. A list of authorities determined as equivalent shall be agreed
to by the Joint Sectoral Committee at the end of the transition period,
with reference to any limitation in terms of inspection type (e.g.,
postapproval or preapproval) or product classes or processes.
(b) The parties will document insufficient evidence of equivalence,
lack of opportunity to assess equivalence or a determination of
nonequivalence, in sufficient detail to allow the authority being
assessed to know how to attain equivalence.
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