[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: 21CFR26.14]
[Page 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. 26.14 Transmission of preapproval inspection reports.
(a) A preliminary notification that an inspection may have to take
place will be made as soon as possible.
(b) Within 15-calendar days, the relevant authority will acknowledge
receipt of the request and confirm its ability to carry out the
inspection. In the European Community (EC), requests will be sent
directly to the relevant authority, with a copy to the European Agency
for the Evaluation of Medicinal Products (EMEA). If the authority
receiving the request cannot carry out the inspection as requested, the
requesting authority shall have the right to conduct the inspection.
(c) Reports of preapproval inspections will be sent within 45-
calendar days of the request that transmitted the appropriate
information and detailed the precise issues to be addressed during the
inspection. A shorter time may be necessary in exceptional cases and
these will be described in the request.
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