In der 20. Ergänzungslieferung des GMP-BERATERs wurden Bereiche aus folgenden Kapiteln aktualisiert:

GMP Praxiswissen:

• Kapitel 5 Pharmawasser
• Kapitel 11 Produktion
• Kapitel 14 Qualitätskontrolle
• Kapitel 17 Herstellung und Prüfung im Lohnauftrag
• Kapitel 18 Audits und Inspektionen

GMP Regularien:

• Kapitel B Behörden, Organisationen und Verbände
• Kapitel E Gesetze Deutschland
• Kapitel G Gesetze Österreich
• Kapitel J ICH Leitlinien
• Kapitel K PIC/S Leitlinien

In der 19. Ergänzungslieferung des GMP-BERATERs wurden folgende Kapitel überarbeitet:

GMP Praxiswissen:
• Kapitel 3 Räume
• Kapitel 14 Qualitätskontrolle

GMP Regularien:
• Kapitel F Gesetze und Richtlinien Schweiz
• Kapitel H Gesetze und Richtlinien Europa
• Kapitel J ICH-Leitlinien
• Kapitel K PIC/S-Richtlinien

What is new?

The recent update of the GMP MANUAL encompasses approx. 660 pages for the
printed version. We have outlined the contents of Update 09 below:

“GMP in Practice”

Updated Chapters:

• Chapter 11: Production
• 11.O References
• Chapter 18: Inspections:
• 18.H Questionnaire for preparing GMP-inspections
• Chapter 20: Continual Improvement Methods:
• 20.E References

New Chapters:

• Chapter 1: Pharmaceutical Quality System:
• Chapter 11: Production
• 11.N Transportation
• Chapter 20: Continual Improvement Methods:
• 20.C Statistical Process Control
• 20.D Process Analytical Technology

“GMP Regulations”

Updated Chapters:

• Chapter C: EU GMP Guide
• C.6: Annex 1 – Annex 20
• Chapter E: ICH-Guidelines
• E.8: ICH Q8 (R2)

New Chapters:

• Chapter E: ICH-Guidelines
• E.10.1: Quality Implementation Working Group on Q8, Q9 and Q10: Questions & Answers
• Chapter F: PIC/S-Guidelines
• F.7: PI 028-1 Aide-mémoire GMP Inspection related to Packaging

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

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