[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: 21CFR26.69]
[Page 275-276]
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 C_``Framework'' Provisions
Sec. 26.69 Monitoring of conformity assessment bodies.
The following shall apply with regard to the monitoring of
conformity assessment bodies (CAB's) listed in subpart B of this part:
(a) Designating authorities shall assure that their CAB's listed in
subpart B of this part are capable and remain capable of properly
assessing conformity of products or processes, as applicable, and as
covered in subpart B of this part. In this regard, designating
authorities shall maintain, or cause to maintain, ongoing surveillance
over their CAB's by means of regular audit or assessment;
(b) The parties undertake to compare methods used to verify that the
CAB's listed in subpart B of this part comply with the relevant
requirements of subpart B of this part. Existing systems for the
evaluation of CAB's may be used as part of such comparison procedures;
(c) Designating authorities shall consult as necessary with their
counterparts, to ensure the maintenance of confidence in conformity
assessment procedures. With the consent of both parties, this
consultation may include joint participation in audits/inspections
related to conformity assessment activities or other assessments of
CAB's listed in subpart B of this part; and
(d) Designating authorities shall consult, as necessary, with the
relevant
[[Page 276]]
regulatory authorities of the other party to ensure that all technical
requirements are identified and are satisfactorily addressed.
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