[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: 21CFR26.21]
[Page 251-254]
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. 26.21 Safeguard clause.
Each party recognizes that the importing country has a right to
fulfill its legal responsibilities by taking actions necessary to ensure
the protection of human and animal health at the level of protection it
deems appropriate. This includes the suspension of the distribution,
product detention at the border of the importing country, withdrawal of
the batches and any request for additional information or inspection as
provided in Sec. 26.12.
Appendix A to Subpart A of Part 26--List of Applicable Laws,
Regulations, and Administrative Provisions
1. For the European Community (EC):
[Copies of EC documents may be obtained from the European Document
Research, 1100 17th St. NW., suite 301, Washington, DC 20036. EC
documents may be viewed on the European Commission Pharmaceuticals Units
web site at http://dg3.eudra.org.]
Council Directive 65/65/EEC of 26 January 1965 on the approximation of
provisions laid down by law, regulation, or administrative action
relating to proprietary medicinal products as extended, widened, and
amended.
Council Directive 75/319/EEC of 20 May 1975 on the approximation of
provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products as extended, widened and
amended.
Council Directive 81/851/EEC of 28 September 1981 on the approximation
of the laws of the Member States relating to veterinary medicinal
products, as widened and amended.
Commission Directive 91/356/EEC of 13 June 1991 laying down the
principles and guidelines of good manufacturing practice for medicinal
products for human use.
[[Page 252]]
Commission Directive 91/412/EEC of 23 July 1991 laying down the
principles and guidelines of good manufacturing practice for veterinary
medicinal products.
Council Regulation EEC No 2309/93 of 22 July 1993 laying down Community
procedures for the authorization and supervision of medicinal products
for human and veterinary use and establishing a European Agency for the
Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 on the wholesale
distribution of medicinal products for human use.
Guide to Good Distribution Practice (94/C 63/03).
Current version of the Guide to Good Manufacturing Practice, Rules
Governing Medicinal Products in the European Community, Volume IV.
2. For the United States:
[Copies of FDA documents may be obtained from the Government
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents,
except the FDA Compliance Program Guidance Manual, may be viewed on
FDA's Internet web site at http://www.fda.gov.]
Relevant sections of the United States Federal Food, Drug, and Cosmetic
Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal Regulations
(CFR) Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799.
Relevant sections of the FDA Investigations Operations Manual, the FDA
Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual,
the FDA Compliance Program Guidance Manual, and other FDA guidances.
Appendix B to Subpart A of Part 26--List of Authorities
1. For the United States: In the United States, the regulatory authority
is the Food and Drug Administration.
2. For the European Community: In the European Community, the regulatory
authorities are the following:
Belgium: Inspection g[eacute]n[eacute]rale de la Pharmacie, Algemene
Farmaceutische Inspectie.
Denmark: Laegemiddelstyrelsen.
Germany: Bundesministerium f[uuml]r Gesundheit for immunologicals: Paul-
Ehrlich-Institut, Federal Agency for Sera and Vaccines.
Greece: [Egr][theta][nu][iota][kappa][omega][sigmav]
[Omega][rho][gamma][alpha][nu][iota][sigma][mu][omega][sigmav]
[Phi][alpha][rho][mu][alpha][kappa][omega][ugr], Ministry of Health and
Welfare, National Drug Organization (E.O.F).
Spain: For medicinal products for human use: Ministerio de Sanidad y
Consumo, Subdirecci[oacute]n General de Control Farmac[eacute]utico. For
medicinal products for veterinary use: Ministerio de Agricultura, Pesca
y Alimentaci[oacute]n (MAPA), Direcci[oacute]n General de la
Producci[oacute]n Agraria.
France: For medicinal products for human use: Agence du
M[eacute]dicament. For veterinary medicinal products: Agence Nationale
du M[eacute]dicament V[eacute]t[eacute]rinaire.
Ireland: Irish Medicines Board.
Italy: For medicinal products for human use: Ministero della
Sanit[agrave], Dipartimento Farmaci e Farmacovigilanza. For medicinal
products for veterinary use: Ministero della Sanit[agrave], Dipartimento
alimenti e nutrizione e sanit[agrave] pubblica veterinaria-Div. IX.
Luxembourg: Division de la Pharmacie et des M[eacute]dicaments.
Netherlands: Staat der Nederlanden.
Austria: Bundesministerium f[uuml]r Arbeit, Gesundheit und Soziales.
Portugal: Instituto da Farm[aacute]cia e do Medicamento (INFARMED).
Finland: L[auml][auml]kelaitos/L[auml]kemedelsverket (National Agency
for Medicines).
Sweden: L[auml]kemedelsverket-Medical Products Agency.
United Kingdom: For human use and veterinary (non-immunologicals):
Medicines Control Agency. For veterinary immunologicals: Veterinary
Medicines Directorate.
European Community: Commission of the European Communities. European
Agency for the Evaluation of Medicinal Products (EMEA).
Appendix C to Subpart A of Part 26--Indicative List of Products Covered
by Subpart A
Recognizing that precise definition of medicinal products and drugs are
to be found in the legislation referred to above, an indicative list of
products covered by this arrangement is given below:
--human medicinal products including prescription and
nonprescription drugs;
--human biologicals including vaccines, and immunologicals;
--veterinary pharmaceuticals, including prescription and
nonprescription drugs, with the exclusion of veterinary immunologicals
(Under 9 CFR 101.2 ``veterinary immunologicals'' are referred to as
``veterinary biologicals'');
--premixes for the preparation of veterinary medicated feeds (EC),
Type A medicated articles for the preparation of veterinary medicated
feeds (United States);
--intermediate products and active pharmaceutical ingredients or
bulk pharmaceuticals (United States)/starting materials (EC).
[[Page 253]]
Appendix D to Subpart A of Part 26--Criteria for Assessing Equivalence
for Post- and Preapproval
I. Legal/Regulatory authority and structures and procedures providing
for post- and preapproval:
A. Appropriate statutory mandate and jurisdiction.
B. Ability to issue and update binding requirements on GMP's and
guidance documents.
C. Authority to make inspections, review and copy documents, and to take
samples and collect other evidence.
D. Ability to enforce requirements and to remove products found in
violation of such requirements from the market.
E. Substantive current good manufacturing requirements.
F. Accountability of the regulatory authority.
G. Inventory of current products and manufacturers.
H. System for maintaining or accessing inspection reports, samples and
other analytical data, and other firm/product information relating to
matters covered by subpart A of this part.
II. Mechanisms in place to assure appropriate professional standards and
avoidance of conflicts of interest.
III. Administration of the regulatory authority:
A. Standards of education/qualification and training.
B. Effective quality assurance systems measures to ensure adequate job
performance.
C. Appropriate staffing and resources to enforce laws and regulations.
IV. Conduct of inspections:
A. Adequate preinspection preparation, including appropriate expertise
of investigator/team, review of firm/product and databases, and
availability of appropriate inspection equipment.
B. Adequate conduct of inspection, including statutory access to
facilities, effective response to refusals, depth and competence of
evaluation of operations, systems and documentation; collection of
evidence; appropriate duration of inspection and completeness of written
report of observations to firm management.
C. Adequate postinspection activities, including completeness of
inspectors' report, inspection report review where appropriate, and
conduct of followup inspections and other activities where appropriate,
assurance of preservation and retrieval of records.
V. Execution of regulatory enforcement actions to achieve corrections,
designed to prevent future violations, and to remove products found in
violation of requirements from the market.
VI. Effective use of surveillance systems:
A. Sampling and analysis.
B. Recall monitoring.
C. Product defect reporting system.
D. Routine surveillance inspections.
E. Verification of approved manufacturing process changes to marketing
authorizations/approved applications.
VII. Additional specific criteria for preapproval inspections:
A. Satisfactory demonstration through a jointly developed and
administered training program and joint inspections to assess the
regulatory authorities' capabilities.
B. Preinspection preparation includes the review of appropriate records,
including site plans and drug master file or similar documentation to
enable adequate inspections.
C. Ability to verify chemistry, manufacturing, and control data
supporting an application is authentic and complete.
D. Ability to assess and evaluate research and development data as
scientifically sound, especially transfer technology of pilot, scale up
and full scale production batches.
E. Ability to verify conformity of the onsite processes and procedures
with those described in the application.
F. Review and evaluate equipment installation, operational and
performance qualification data, and evaluate test method validation.
Appendix E to Subpart A of Part 26--Elements To Be Considered in
Developing a Two-Way Alert System
1. Documentation
--Definition of a crisis/emergency and under what circumstances an alert
is required
--Standard Operating Procedures (SOP's)
--Mechanism of health hazards evaluation and classification
--Language of communication and transmission of information
2. Crisis Management System
--Crisis analysis and communication mechanisms
--Establishment of contact points
--Reporting mechanisms
3. Enforcement Procedures
--Followup mechanisms
--Corrective action procedures
[[Page 254]]
4. Quality Assurance System
--Pharmacovigilance programme
--Surveillance/monitoring of implementation of corrective action
5. Contact Points
For the purpose of subpart A of this part, the contact points for the
alert system will be:
A. For the European Community:
the Executive Director of the European Agency for the Evaluation of
Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London E14
4HB, England. Telephone 44.171-418 8400, Fax 418-8416.
B. For the United States :
Biologics: Director, Office of Compliance and Biologics Quality (HFM-
600), 1401 Rockville Pike, Rockville, MD 20852, phone: 301-827-6190,
fax: 301-594.1944.
Human Drugs: Director, Office of Compliance (HFD-300), 5600 Fishers
Lane, Rockville, MD 20857, phone: 301-827-8910, fax: 301-827-8901.
Veterinary Drugs: Director, Office of Surveillance and Compliance (HFV-
200), MPN II, 7500 Standish Pl., Rockville, MD 20855-2773, phone: 301-
827-6644, fax: 301-594.1807.
[63 FR 60141, Nov. 6, 1998, as amended at 69 FR 48775, Aug. 11, 2004]
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