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[资源] FDA生物制品指导原则

Comparability Protocols Protein Drug Products and Biological Products -- Chemistry, Manufacturing, and Controls Information

TABLE OF CONTENTS
I. INTRODUCTION ................................................................................................................1
II. BACKGROUND...............................................................................................................2
A. What is a Comparability Protocol? ....................................................................................4
B. What is the Benefit of Using a Comparability Protocol? ..................................................4
C. When and Why Were Comparability Protocols Created?.................................................4
D. Why is A Guidance on Comparability Protocols Being Provided? ...................................5
E. Where Can More Information on Postapproval Changes and Assessment of
Comparability Be Found? ..........................................................................................................5
III. WHAT TO CONSIDER IN PLANNING A COMPARABILITY PROTOCOL.........6
A. How Does a Comparability Protocol Affect the Reporting of CMC Changes? ...............6
B. When Might a Comparability Protocol Be Useful for a CMC Change?...........................6
C. When Might a Comparability Protocol Be Inappropriate?...............................................8
IV. PROCEDURES FOR COMPARABILITY PROTOCOLS ...........................................9
A. How Should a Comparability Protocol Be Submitted?......................................................9
B. How are Changes and Study Results Submitted After a Comparability Protocol is
Approved? ...............................................................................................................................10
C. What If Study Results Do Not Meet the Criteria Specified in the Approved
Comparability Protocol? ..........................................................................................................10
D. When Does a Comparability Protocol Become Obsolete?.............................................10
E. How is an Approved Comparability Protocol Modified? ................................................11
V. CONTENT OF A COMPARABILITY PROTOCOL.......................................................11
A. What are the Basic Elements of a Comparability Protocol? ...........................................12
B. Does FDA Have Specific Concerns About Changes in the Manufacturing Process That
Should Be Addressed in a Comparability Protocol? ...............................................................15
C. Does FDA Have Specific Concerns About Changes in Analytical Procedures That
Should Be Addressed in a Comparability Protocol? ...............................................................16
D. Does FDA Have Specific Concerns About Changes in Manufacturing Equipment That
Should Be Addressed in a Comparability Protocol? ...............................................................17

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