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Table Of Contents

I. INTRODUCTION
II. BACKGROUND
A. Regulatory Framework
B. Technical Framework
III. SCOPE
IV. BUILDINGS AND FACILITIES
A. Critical Area – Class 100 (ISO 5)
B. Supporting Clean Areas
C. Clean Area Separation
D. Air Filtration
1. Membrane
2. High-Efficiency Particulate Air (HEPA)7
E. Design
V. PERSONNEL TRAINING, QUALIFICATION, & MONITORING
A. Personnel
B. Laboratory Personnel
C. Monitoring Program
VI. COMPONENTS AND CONTAINER/CLOSURES
A. Components
B. Containers/Closures
1. Preparation
2. Inspection of Container Closure System
VII. ENDOTOXIN CONTROL
VIII. TIME LIMITATIONS
IX. VALIDATION OF ASEPTIC PROCESSING AND STERILIZATION
A. Process Simulations
1. Study Design
2. Frequency and Number of Runs
4. Size of Runs
5. Line Speed
6. Environmental Conditions
7. Media
8. Incubation and Examination of Media-Filled Units
9. Interpretation of Test Results
B. Filtration Efficacy
C. Sterilization of Equipment, Containers, and Closures
1. Qualification and Validation
2. Equipment Controls and Instrument Calibration
X. LABORATORY CONTROLS
A. Environmental Monitoring
1. General Written Program
2. Establishing Levels and a Trending Program
3. Disinfection Efficacy
4. Monitoring Methods
B. Microbiological Media and Identification
C. Prefiltration Bioburden
D. Alternate Microbiological Test Methods
E. Particle Monitoring
XI. STERILITY TESTING
A. Microbiological Laboratory Controls
B. Sampling and Incubation
C. Investigation of Sterility Positives
XII. BATCH RECORD REVIEW: PROCESS CONTROL DOCUMENTATION
APPENDIX 1: ASEPTIC PROCESSING ISOLATORS
APPENDIX 2: BLOW-FILL- SEAL TECHNOLOGY
APPENDIX 3: PROCESSING PRIOR TO FILLING AND SEALING OPERATIONS
REFERENCES
RELEVANT GUIDANCE DOCUMENTS
GLOSSARY
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cGMP Sterile FDA

cGMP Sterile FDA

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Published by vidya mandava

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Published by: vidya mandava on Nov 14, 2011
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11/05/2012

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