Appendix D to Subpart A of Part 26 - Criteria for Assessing Equivalence for Post- and Preapproval
21:1.0.1.1.20.1.63.22.4 : Appendix D
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.