Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (eBook, PDF) - Burdick, Richard K.; LeBlond, David J.; Pfahler, Lori B.; Quiroz, Jorge; Sidor, Leslie; Vukovinsky, Kimberly; Zhang, Lanju
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Chapter 1. Introduction.- Chapter 2. Statistical Methods for CMC Applications.- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance.- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance.- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance.- Chapter 6. Analytical Procedures.- Chapter 7. Specifications.- Chapter 8. Stability.- Chapter 9. Analytical Comparability and Similarity.