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Book 4C:  2017 Good Manufacturing Practice in the European Union, Reference Guide

Book 4C: 2017 Good Manufacturing Practice in the European Union, Reference Guide

$ 15.95

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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 in 2015. (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:  $15.95             • 250-499 copies:  $15.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

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 (Current and previous) 
      • Chapter 4: Documentation
      • Chapter 5: Production (Current and previous)
      • 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

 

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