This spiral-bound, 5.5" x 8.5" book is a compilation of the official Eudralex GMP Guidleines in reduced size. It includes current guidelines as well as finalized guidelines coming into effect at a later date. (300 pages)
How is this Book Used?
• As a training aid for new and existing staff
• As an on-the-job reference source
• As a preparatory aid for an FDA inspection
What's the Price?
• 1-249 copies: $18.95 • 250-499 copies: $17.95
• 500-749 copies: $16.95 • 750+ copies: $15.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
The Rules Governing Medicinal Products in the EU
Volume 4: Good Manufacturing Practice Guidelines
Part I - Basic Requirements for Medicinal Products
• Chapter 1: Pharmaceutical Quality System
• Chapter 2: Personnel
• Chapter 3: Premises and Equipment
• Chapter 4: Documentation
• Chapter 5: Production
• Chapter 6: Quality Control
• Chapter 7: Outsourced Activities
• Chapter 8: Complaints and Product Recall
• Chapter 9: Self Inspection
Part II - Basic Requirements for Active Substances used as Starting Materials
Part III - GMP Related Documents
- Explanatory Notes on Site Master File
- ICH Q9 Quality Risk Management
- ICH Q10 Note for Guidance on Pharmaceutical Quality System
- MRA Batch Certificate
- Template for the 'Written Confirmation' for Active Substances Exported to the European Union for Medicinal Products for Human Use
- Guideline on Setting Health Based Exposure Limits for use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities
- Guidelines of 19 March 2015 on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use
Selected Annexes
• Annex 1: Manufacture of Sterile Medicinal Products
• Annex 2: Manufacture of Biological Active Substances and Medicinal Products for
Human Use
• Annex 11: Computerised Systems
• Annex 13: Manufacture of Investigational Medicinal Products
• Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma
Glossary
• Commission Directive 2003/94/EC of 8 October 2003 on GMP
• Commission Delegated Regulation (EU) No. 1252/2014 with Regard to Principles
and Guidelines of GMP