MHRA, EU & ICH GMP Handbook

MHRA, EU & ICH GMP Handbook with the new ICH Q7 GMP Auditor's Check List.

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