Quality systems and controls for pharmaceuticals

List of figures.

List of tables.

Glossary of terms and acronyms.

Glossary of mathematical and statistical symbols.

SECTION A.

1. Introduction.

1.1 The process of finding new lead medicines.

1.2 A drug discovery framework.

2. Technology transfer and the climate of change.

2.1 Innovation and research.

2.2 Method transfer.

3. Quality systems structure and a maximum quality environment.

3.1 The quality gurus and models for assurance.

3.2 A cycle of continual improvement.

3.3 Management structure and a functioning department.

3.3.1 Organisational efficiency.

3.3.2 Standards and the ISO models.

3.3.3 Kaizen, quality circles and the quality spiral.

SECTION B.

4. Validation.

4.1 Process and manufacturing validation activities.

4.1.1 Manufacturing validation (processed product).

4.1.2 Cleaning validation.

4.1.3 Software and PLCs.

4.1.4 HACCP.

4.1.5 Ready to start manufacturing?.

4.2 Valid analytical methodologies (VAMs).

4.2.1 Model Systems and GLP.

4.2.2 Modes of real practice.

5. Good manufacturing practices.

5.1 Manufacture of standard products.

5.1.1 Solid dosages: tablets, capsules and soft-gelatin capsules.

5.1.2 Transdermal delivery and dressings.

5.1.3 Non-sterile liquids and paediatric syrups.

5.1.4 Topical (emulsion) products, including medicated shampoos.

5.2 Manufacture of materials requiring specialised production facilities.

5.2.1 Parenterals.

5.2.2 Diagnostic apparatus.

5.3 Quality assurance aspects of medical gases, devices and miscellaneous product manufacture.

5.3.1 Multi-component packaged medicinal products, including inhalers.

5.3.2 Radiopharmaceuticals and imaging agents.

5.3.3 Anaesthetics.

6. Process control via numerical means.

6.1 Charting and quality inspection.

6.2 Sampling plans.

6.3 Measures of process compliance and variation.

7. Product verification and the role of qualified personnel.

7.1 Batch documentation.

7.2 Standard operating procedures.

7.3 Guides, overviews and validation plans.

7.4 The duties of the qualified person.

8. In-process and on-process QC testing and control.

8.1 Process analytical technologies.

8.1.1 On-line sensors.

8.1.2 Hyphenation in manufacture and process diagnostics.

8.2 Analytical validation and clinical test validation (CTV).

8.3 LIMS and automation.

8.3.1 Laboratory management.

8.3.2 Scope and future directions.

SECTION C.

9. Applications of QA to new medicinal products and new chemical entities formulation.

9.1 Start-up and initialisation.

9.2 Raw materials control.

9.3 The validation life cycle.

9.4 Top-down or bottom-up validations.

10. New products manufacturing.

10.1 From inception to market place.

10.1.1 Requirements for a successful new product.

10.1.2 The product life cycle.

10.1.3 Innovations, patenting and intellectual property.

10.2 New product development: product design and specification.

10.2.1 The target product profile.

10.2.2 Quality function deployment.

11. Questions and problems.

11.1 Specimen examples and exam...