Contains Nonbinding Recommendations

TABLE OF CONTENTS

I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND ............................................................................................................... 3
A. Process Validation and Drug Quality .......................................................................................... 3
B. Approach to Process Validation ................................................................................................... 4
III. STATUTORY AND REGULATORY REQUIREMENTS FOR PROCESS
VALIDATION................................................................................................................... 5
IV. RECOMMENDATIONS.................................................................................................. 7
A. General Considerations for Process Validation .......................................................................... 7
B. Stage 1 ― Process Design.............................................................................................................. 8
1. Building and Capturing Process Knowledge and Understanding................................................... 8
2. Establishing a Strategy for Process Control.................................................................................... 9
C. Stage 2 ― Process Qualification ................................................................................................. 10
1. Design of a Facility and Qualification of Utilities and Equipment ............................................... 10
2. Process Performance Qualification............................................................................................... 11
3. PPQ Protocol................................................................................................................................. 12
4. PPQ Protocol Execution and Report............................................................................................. 13
D. Stage 3 ― Continued Process Verification ................................................................................ 14
V. CONCURRENT RELEASE OF PPQ BATCHES ...................................................... 16
VI. DOCUMENTATION...................................................................................................... 17
VII. ANALYTICAL METHODOLOGY.............................................................................. 17
GLOSSARY................................................................................................................................. 18
REFERENCES............................................................................................................................ 19