[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: 21CFR26.3]
[Page 248]
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. 26.3 Scope.
(a) The provisions of this subpart shall apply to pharmaceutical
inspections carried out in the United States and Member States of the
European Community (EC) before products are marketed (hereafter referred
to as ``preapproval inspections'') as well as during their marketing
(hereafter referred to as ``postapproval inspections'').
(b) Appendix A of this subpart names the laws, regulations, and
administrative provisions governing these inspections and the good
manufacturing practices (GMP's) requirements.
(c) Appendix B of this subpart lists the authorities participating
in activities under this subpart.
(d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of subpart
C of this part do not apply to this subpart.
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