[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: 21CFR26.20]
[Page 251]
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. 26.20 Alert system.
(a) The details of an alert system will be developed during the
transitional period. The system will be maintained in place at all
times. Elements to be considered in developing such a system are
described in Appendix E of this subpart.
(b) Contact points will be agreed between both parties to permit
authorities to be made aware with the appropriate speed in case of
quality defect, recalls, counterfeiting, and other problems concerning
quality, which could necessitate additional controls or suspension of
the distribution of the product.
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