[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26A App D]

[Page 253-254]

                        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 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. 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.

[[Page 254]]

 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.