• Detailed changes to the EU guide to good manufacturing practice
• Detailed revisions to the EU Directive on medicinal products for human use
• The new Directive on the Principles and Guidelines on Good Manufacturing Practice of Medicinal Products for Human Use
• Restructured contents and clearer text design
• A subject index.

Section 1: Medicines and Healthcare products Regulatory Agency (MHRA)

1. MHRA: Licensing, inspection and enforcement for human medicines

Section 2: Guidance on Good Manufacturing Practice (GMP)

2. EU guidance on good manufacturing practice

Part 1: Basic requirements for medicinal products

1. Quality management

2. Personnel

3. Premises and equipment

4. Documentation

5. Production

6. Quality control

7. Contract manufacture and analysis

8. Complaints and product recall

9. Self inspection

Annexes

Part 2: Basic requirements for active substances used as starting materials

3. UK guidance on manufacture

Section 3: Legislation on Manufacture

4. EU legislation on manufacture

5. UK legislation on manufacture

Section 4: Guidance on wholesale distribution practice

6. EU guidance on wholesale distribution practice

7. UK guidance on wholesale distribution practice

Section 5: Legislation on Wholesale Distribution

8. EU legislation on wholesale distribution

9. UK legislation on wholesale distribution

Section 6: Glossary of Legislation

Section 7: Index