by Dipak K. Sarker
Quality Systems and Controls for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices.
Quality Systems and Controls for Pharmaceuticals is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice.
Contents
- The process of finding new lead medicines
- A drug discovery framework
2. Technology transfer and the climate of change
- Innovation and research
- Method transfer
3. Quality systems structure and a maximum quality environment
- The quality gurus and models for assurance
- A cycle of continual improvement
- Management structure and a functioning department
4. Validation
- Process and manufacturing validation activities
- Valid analytical methodologies (VAMs)
5. Good manufacturing practices
- Manufacture of standard products
- Manufacture of materials requiring specialised production facilities
- Quality assurance aspects of medical gases, devices and miscellaneous product manufacture
6. Process control via numerical means
- Charting and quality inspection
- Sampling plans
- Measures of process compliance and variation
7. Product verification and the role of qualified personnel
- Batch documentation
- Standard operating procedures
- Guides, overviews and validation plans
- The duties of the qualified person
8. In-process and on-process QC testing and control
- Process analytical technologies
- Analytical validation and clinical test validation (CTV)
- LIMS and automation
9. Applications of QA to new medicinal products and new chemical entities formulation
- Start-up and initialisation
- Raw materials control
- The validation life cycle
- Top-down or bottom-up validations
10. New products manufacturing
- From inception to market place
- New product development: product design and specification
11. Questions and problems
- Specimen examples and exam questions
- Model answers to examples
Index
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