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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

2009-11-26

What is new?

The eighth update of the GMP MANUAL encompasses approx. 650 pages for the
printed version. We have outlined the contents of Update 08 below:

“GMP in Practice”

Updated Chapters:

  • Chapter 3 Premises:
    3.A: Official Requirements
    3.C: Room Classes
    3.F: Building Services
  • Chapter 8: Cleaning Validation (entire chapter)
  • Chapter 9: Computer Validation:
    9.B Regulatory Aspects
    9.D Risk Analysis and System Classification
  • Chapter 11: Production
    11.E.3.2 US Requirements

New Chapters:

  • Chapter 3 Premises:
    3.E: Barrier Systems and Isolators
    3.H: Process Gases
    3.I: Qualification of Premises and Air-Conditioning Systems
    3.J: Monitoring of HVAC Systems
    3.K: References
  • Chapter 8: Cleaning Validation:
    8.K References
  • Chapter 9: Computer Validation:
    9.H References
  • Chapter 14: Laboratory and analytical controls:
    14.L Pharmacopoeias
    14.M References

“GMP Regulations”

Updated Chapters:

  • Chapter A: Information
    A.3: Abbreviations
  • Chapter D: USA: CFR and FDA Guidelines
    D.13: 21 CFR Part 820
    D.16: Federal Food, Drug, and Cosmetic Act (link to revised version)
  • Chapter E: ICH-Guidelines
    E.4.B: ICH Q4B Annex 2 and Annex 3 (now Step 4)

New Chapters:

  • Chapter D: USA: CFR and FDA Guidelines
    D.15: Guidance for Industry: CGMP for Phase 1 Investigational Drugs
  • Chapter E: ICH-Guidelines
    E.4.B: ICH Q4B: Annex 4–10

 
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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