• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices


>>> REGISTER for our free GMP Newsletter LOGFILE


The GMP MANUAL is the most powerful and dependable reference tool in the world.


Indispensable for pharmaceutical manufacturers, suppliers, consultants and engineering companies that need the most updated information available. Start right away with the GMP MANUAL. Order now your personal copy.




GMP in Practice: 24 chapters written by internationally renowned industry experts.


GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.



>>> More information

Updates Forecast & History


What is new?

The seventh Update of the GMP MANUAL encompasses approx. 500 pages for the printed version and additionally 400 pages for the CD/online version. For a brief overview of the contents see below:

“GMP in Practice”

Updated Chapters:

  • Chapter 11:   Production

New Chapters:

  • Chapter 19:   Quality Unit (Qualified Person)
  • Chapter 20:   Continual Improvement Methods (Six Sigma)
“GMP Regulations”

Updated chapters

  • Chapter C.1          EU-GMP Guide: Introduction
  • Chapter C.6.3       EU-GMP Guide:Annex 3 Manufacture of Radiopharmaceuticals
  • Chapter C.6.7       EU-GMP Guide:Annex 7 Manufacture of Herbal Medicinal Products
  • Chapter E.8          ICH Q8 (R1) Pharmaceutical Development
  • Chapter F      PIC/S PI 007 Recommendation on the Validation of Aseptic Processes

New chapters

  • Chapter C.10        EU-GMP Guide Compilation of Community Procedures
  • Chapter E.1.D       ICH Q1D Bracketing and Matrixing Designs for Stability Testing of new Drug Substances and Products
  • Chapter E.1.E        ICH Q1E Evaluation for Stability Data
  • Chapter G.1           WHO Quality Assurance of Pharmaceuticals (only on CD/online)

For a brief overview of the contents (approx. 900 pages) of this sixth update please
see the following summaries:

In “GMP in Practice” we updated the following chapters:
• Chapter Contributors
• Chapter 4 Equipment
• Chapter 5 Pharmaceutical Water
• Chapter 14 Laboratory and Analytical Control

In “GMP Regulations” we updated the following chapters:
• Chapter D.1 US Regulations 21 CFR part 210 and 211
New in “GMP Regulations” is:
• Chapter E.10 ICH Q10 Pharmaceutical Quality System


For a brief view of the contents (more than 1,000 pages) of this fifth update please
see the following summaries:

In “GMP in practice” we have updated the following chapters:
• Chapter 3 Premises
• Chapter 16 Research and Development
• Chapter 18 Inspections

In “GMP regulations” we updated the following chapters:
• Chapter A, we integrated former chapter B.1-B.4 in chapter A
• Chapter C.6.20 EU-GMP-Guide Annex 20 Quality Risk Management
• Chapter E ICH Guidelines, this chapter is now reorganised
New in “GMP regulations” is:
• Chapter B with 3 Japanese Regulations
• Chapter E.5 ICH Q5 Five Regulations on Biotechnology Products
• Chapter E.8 ICH Q8 Pharmaceutical Development

Page 2/2    1   2