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GMP MANUAL

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

 

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

 

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Updates Forecast & History

2009-09-25

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)
 
2009-03-31

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

 
2008-11-01

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

 
 
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