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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

2011-10-04

What is new?

The recent update of the GMP MANUAL encompasses approx. 850 pages. In early 2011, regulatory requirements on Documentation, Computer Validation and Process Validation have been updated and the revised versions of the respective documents were in the focus of the “GMP Regulations” part of Update 11. Meanwhile, the corresponding chapters in the “GMP in Practice” part were subject to an in-depth review and represent the principal items of the present Update 12.
Vice versa, chapter 23 on Medical Devices was introduced in the “GMP in Practice” part in Update 11 as a new topic, which will now be complemented by a chapter in the “GMP Regulations” part, including EU Directives which are the underlying regulatory documents in the European region.

The contents of Update 12 are outlined below:

“GMP in Practice”

New Chapters:

  • Chapter 7.E.4: Process validation as a three stage lifecycle model
  • Chapter 7.F: References
  • Chapter 9.H: References
  • Chapter 15.G: References

Updated Chapters:

  • Chapter 7: Process Validation
  • Chapter 9: Computer Validation
  • Chapter 15.E: Site Master File

“GMP Regulations"”

New Chapters:

  • Chapter C: EU Directives and Guideline
    • C.8.2: EU GMP Guide Part III: Quality Risk Management
    • C.8.3: EU GMP Guide Part III: Pharmaceutical Quality System
    • C.8.4: EU GMP Guide Part III: Internationally harmonised requirements for batch certification
    • C.11: EU Directives on Medical Devices

Updated Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.6.14: Annex 14 Blood and Blood products
    • C.10: Compilation of Community Procedures
  • Chapter D: USA: CFR and FDA Guidelines
    • D.1.1: 21 CFR 210
  • Chapter F: PIC/S Guidelines
    • F.2: PIC/S PI 007-6 Recommendation on the Validation of Aseptic Processes
  • Chapter H Information:
    • H.1: Abbreviations
    • H.2: Glossary
    • H.3: Adresses
    • H.4: References

 
2011-05-10

What is new?

The recent update of the GMP MANUAL encompasses approx. 620 pages. Due to the fact that a lot of regulatory requirements have been updated and some new documents were published since the beginning of the year, this  update encompasses many new and updated chapters from the “GMP Regulation” Part of the MANUAL. Within the “GMP in Practice” Part, you will find a new and very comprehensive chapter on Medical Devices. With this chapter an important subject area has been introduced into the range of GMP related topics within the GMP MANUAL.

The contents of Update 11 are outlined below:

“GMP in Practice”

New Chapters:

  • Chapter 23: Medical Devices

Updated Chapters:

  • Chapter 7: Process Validation
    • 7.A: Official Requirements

“GMP Regulations”

New Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.8: EU GMP Guide, Part III
  • Chapter D: USA: CFR and FDA Guidelines
    • D.17: Pre-Approval Inspections
  • Chapter F: PIC/S Guidelines
    • F.8: PIC/S PI 032-2: Recommendation GMP Annex 1 Revision 2008, Interpretation of Most Important Changes for the Manufacture of Sterile Medicinal Products

Updated Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.1 EU GMP Guide: Introduction
    • C.4: Part I Basic Requirements for Medicinal Products
    • C.6.11: Annex 11 Computerized Systems
  • Chapter D: USA: CFR and FDA Guidelines
    • D.2: Guidance for Industry: Process Validation: General Principles and Practices
  • Chapter E: ICH Guidelines
    • E.3.C: ICH Q3C(R5) Guideline for residual solvents
  • Chapter F: PIC/S Guidelines
    • F.5: PIC/S PE 008-4 Explanatory notes for Industry on the preparation of a Site Master File

 
2010-10-05

available since November 2010

What is new?

The recent update of the GMP MANUAL encompasses approx. 530 pages for the printed version. Additionally, another 250 pages are provided for the electronic media (CD ROM and Online version).
The contents of Update 10 are outlined below:

“GMP in Practice”

Updated Chapters:

  • Chapter 17: Contractors and Suppliers (new title):
    • 17.A Contract Manufacture
    • 17.B Contract Analysis
  • Chapter 21: Active and Inactive Ingredients (new title):
    • 21.A GMP for Active Pharmaceutical Ingredients (APIs)

New Chapters:

  • Chapter 17: Contractors and Suppliers (new title):
    • 17.C Suppliers
    • 17.D References
  • Chapter 18: Inspections
    • 18.I References
  • Chapter 21: Active and Inactive Ingredients (new title):
    • 21.B GMP for APIs – considerations on special topics
    • 21.C Excipients
    • 21.D References

“GMP Regulations”

Updated Chapters:

  • Chapter C: EU Directives and Guidelines (new title)
    • C.5: Part II – Basic Requirements for Active Substances used as Starting Materials

New Chapters:

  • Chapter C: EU Directives and Guidelines (new title)
    • C.10 Compilation of Community Procedures on Inspections and Exchange of Information: Procedure for dealing with serious GMP non-compliance for voiding/suspension of CEPS thus requiring coordinated administrative action
  • Chapter G: GMP of other Regions
    • G.1.3 WHO Technical Report Annex 5: Good Distribution Practice
    • G.2 Health Canada Good Manufacturing Practices (GMP) Guidelines, 2009 Edition
 
2010-05-26

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

 
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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