Vaccines, Blood & Biologics
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Regulatory SOPP 8401.4 Review Responsibilities for the CMC Section of Biologic License Applications and Supplements
| SOPP 8401.1 | Version #1 | Date: Apr. 8, 2005 |
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Appendix 1 - Table of Assignments
| Product Office | Div of Manuf & Prod Quality (DMPQ) | |
|---|---|---|
| Drug Substance | ||
| A. Description And Characterization | 1° | FYI |
| 1. Description | 1° | FYI |
| 2. Characterization / Proof of Structure | 1° | FYI |
| a. Physicochemical Characterization of Reference Stds & Lots | 1° | FYI |
| b. Biological Activity | 1° | FYI |
| B. Manufacturer(s) | ||
| 1. Identification | Shared | Shared |
| 2. Floor Diagram | FYI | 1° |
| 3. Other Products | Shared | Shared |
| 4. Contamination Precautions | Shared | Shared |
| C. Method(s) Of Manufacture | ||
| 1. Raw Materials And Reagents | 1° | Insp |
| 2. Flow Charts | 1° | Insp |
| 3. Detailed Description | 1° | FYI |
| a. Animal Sources | 1° | FYI |
| b. Cellular Sources | Shared | Shared |
| i. Cell Substrate / Host Cell / Expression Vector System | 1° | FYI |
| ii. Cell Seed Lot System | 1° | Insp |
| c. Human Sources | 1° | FYI |
| d. Virus Sources | 1° | FYI |
| e. Synthetic Sources | 1° | FYI |
| 4. Batch Records | Shared | Shared |
| D. Process Controls | Shared | Shared |
| E. Reference Standard(s) | 1° | FYI |
| F. Specifications / Analytical Methods | ||
| 1. Drug Substance Specifications And Tests | 1° | FYI |
| 2. Impurities Profile | 1° | |
| G. Container/Closure System | FYI | 1° |
| H. Drug Substance Stability | 1° | As noted |
| Drug Product | ||
| A. Composition | 1° | FYI |
| B. Specifications & Methods For Drug Product Ingredients | 1° | FYI |
| 1. Drug Substances Including All Active Ingredients | 1° | FYI |
| 2. Excipients | 1° | FYI |
| 3. Adjuvants | 1° | FYI |
| 4. Preservatives | 1° | As noted |
| C. Manufacturer(s) | Shared | Shared |
| D. Methods Of Manufacture And Packaging | As noted | 1° |
| E. Specifications & Test Methods For Drug/ In Vitro Product | Shared | Shared |
| F. Container/Closure System | FYI | 1° |
| G. Microbiology | 1° | |
| H. Lyophilization | FYI | 1° |
| I. Drug Product Stability | 1° | FYI |
| J. Investigational Product/Formulation | 1° | FYI |
| K. Environmental Assessment | 1° | |
| L. Method Validation | Shared | Shared |
| M. Establishment Description Section | 1° | |
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