as of 2019 - 08 - 15
16 Research and Development
16.A General conditions and legal requirements
Summary
16.B Development phases and GMP requirements
16.B.1 Formulation development
16.B.2 Analytical development
16.B.3 Manufacturing and testing of stability samples
16.B.4 Packaging development
16.B.5 Process development
16.B.6 Cleaning verification and validation
16.B.7 Process optimization: Basic principles for process validation
16.B.8 Up scaling to pilot plant and production scale
16.B.9 Handover to other manufacturing sites
Summary
16.C Interfaces to GLP and GCP
16.C.1 GLP – Good Laboratory Practice
16.C.1.1 Comparison of GLP – GMP
16.C.2 GCP – Good Clinical Practice
16.C.3 Interfaces between the areas regulated by GMP and those regulated by GCP
Summary
16.D Manufacture and control of clinical samples
16.D.1 Prerequisites for the approval of clinical investigations
16.D.2 Manufacturing of clinical samples and comparator drugs
16.D.3 Packaging and labeling
16.D.3.1 Blinding and randomization
16.D.4 Control and release of investigational medicinal products
16.D.4.1 Product release of investigational drugs is often performed in several stages
16.D.5 Storage and shipment of investigational drugs
16.D.6 Returns, recalls and destruction of clinical samples
Summary
16.E Documentation and recording of changes during development
Summary
16.F Development report
Summary
16.G Quality by design (QbD)
Summary:
16.G.1 Introduction
16.G.2 The Regulatory Framework
16.G.2.1 The Origins Lie With FDA
16.G.2.2 The European Perspective
16.G.2.3 The role of the ICH
16.G.3 The New Quality Paradigm
16.G.4 Applying Quality by Design
16.G.4.1 Designing the Quality Target Product Profile
16.G.4.2 Identifying Critical Quality Attributes
16.G.4.3 Determining the Critical Process Parameters
16.G.4.4 Establishing the Design Space
16.G.4.5 Developing the Control Strategy
16.G.5 Implementing Quality by Design
16.G.6 Application Examples
16.G.6.1 Pharmaceutical Microbiology Example
16.G.6.2 Design of Experiment Example
16.G.6.3 Mock Examples
16.G.7 Outlook
16.H References
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