[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.1]

[Page 253]
 
                        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 REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE 
PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents
 
     Subpart A--Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices
 
Sec. 26.1   Definitions.


    (a) Enforcement means action taken by an authority to protect the 
public from products of suspect quality, safety, and effectiveness or to 
assure that products are manufactured in compliance with appropriate 
laws, regulations, standards, and commitments made as part of the 
approval to market a product.
    (b) Equivalence of the regulatory systems means that the systems are 
sufficiently comparable to assure that the process of inspection and the 
ensuing inspection reports will provide adequate information to 
determine whether respective statutory and regulatory requirements of 
the authorities have been fulfilled. Equivalence does not require that 
the respective regulatory systems have identical procedures.
    (c) Good Manufacturing Practices (GMP's). [The United States has 
clarified its interpretation that under the MRA, paragraph (c)(1) of 
this section has to be understood as the U.S. definition and paragraph 
(c)(2) as the EC definition.]
    (1) GMP's mean the requirements found in the legislations, 
regulations, and administrative provisions for methods to be used in, 
and the facilities or controls to be used for, the manufacturing, 
processing, packing, and/or holding of a drug to assure that such drug 
meets the requirements as to safety, and has the identity and strength, 
and meets the quality and purity characteristics that it purports or is 
represented to possess.
    (2) GMP's are that part of quality assurance which ensures that 
products are consistently produced and controlled to quality standards. 
For the purpose of this subpart, GMP's include, therefore, the system 
whereby the manufacturer receives the specifications of the product and/
or process from the marketing authorization/product authorization or 
license holder or applicant and ensures the product is made in 
compliance with its specifications (qualified person certification in 
the EC).
    (d) Inspection means an onsite evaluation of a manufacturing 
facility to determine whether such manufacturing facility is operating 
in compliance with GMP's and/or commitments made as part of the approval 
to market a product.
    (e) Inspection report means the written observations and GMP's 
compliance assessment completed by an authority listed in Appendix B of 
this subpart.
    (f) Regulatory system means the body of legal requirements for 
GMP's, inspections, and enforcements that ensure public health 
protection and legal authority to assure adherence to these 
requirements.

[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]