MHRA, EU & ICH GMP Handbook

MHRA Guidance

Good Manufacturing Practice and Good Distribution Practice

European Union EMA Good Manufacturing Practice

- EU GMPs Chapter 1 - 9
    - Pharmaceutical Quality System
    - Personnel
    - Premise and Equipment
    - Documentation
    - Production
    - Quality Control
    - Outsourced Activities
    - Complaints and Product Recall
    - Self Inspection
- Annex 1 Sterile Medicinal Products
- Annex 8 Sampling of Starting and Packaging Materials
- Annex 11 Computerized Systems
- Annex 15 - Qualification and Validation
- Annex 16 - Certification by a Qualified Person and Batch Release
- Annex 19 Reference and Retention Samples

International Council for Harmonisation
- ICH Q7 GMPs for APIs
- ICH Q7 Auditor's Checklist
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Systems