[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: 21CFR26.1]
[Page 247-248]
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. 26.1 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.
[[Page 248]]
(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]
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