[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: 21CFR26.11]
[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. 26.11 Start of operational period.
(a) The operational period shall start at the end of the transition
period and its provisions apply to inspection reports generated by
authorities listed as equivalent for the inspections performed in their
territory.
(b) In addition, when an authority is not listed as equivalent based
on adequate experience gained during the transition period, the Food and
Drug Administration (FDA) will accept for normal endorsement (as
provided in Sec. 26.12) inspection reports generated as a result of
inspections conducted jointly by that authority on its territory and
another authority listed as equivalent, provided that the authority of
the Member State in which the inspection is performed can guarantee
enforcement of the findings of the inspection report and require that
corrective measures be taken when necessary. FDA has the option to
participate in these inspections, and based on experience gained during
the transition period, the parties will agree on procedures for
exercising this option.
(c) In the European Community (EC), the qualified person will be
relieved of responsibility for carrying the controls laid down in
Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix
A of this subpart) provided that these controls have been carried out in
the United States and that each batch/lot is accompanied by a batch
certificate (in accordance with the World Health Organization
Certification Scheme on the Quality of Medicinal Products) issued by the
manufacturer certifying that the product complies with requirements of
the marketing authorization and signed by the person responsible for
releasing the batch/lot.
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