The recent update of the GMP MANUAL (April 2013)c encompasses approx. 650 pages. The contents of Update No.15 are outlined below:

“GMP in Practice”

New Chapters:

• 15: Documentation
  
  • 15.F: Electronic Batch Recording and Batch Release (replaces 15.C.3)
  • 15.G: Document Management Systems
• 19: Quality Unit
  
  • 19.E: Deviations (replaces 11.K)
  • 19.H: Complaints and Recalls

Updated Chapters:

• 19: Quality Unit
  
  • 19.F: Batch Record Review (formerly 15.C.5)
  • 19.G: Product Quality Review and Annual Product Review (formerly 15.F)
• Chapter 22: Excipients (formerly 21.C)

“GMP Regulations”

New Chapters:

• B: National Bodies and Pharmaceutical Associations
• C: EU Directives and Guidelines
  
  • C.8.5: Template for the “written confirmation” for active substances exported to the European Union for medicinal products for human use
  • C.8.5.1: Importation of Active Substances for Medicinal Products for Human Use; Questions and Answers
  • C.14: Guidelines on Good Distribution Practice of Medicinal Products for Human Use
• E: ICH Guidelines
  
  • E.10.2: ICH Quality Implementation Working Group: Points to Consider (R2); ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
  • E.11: ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
• F: PIC/S Guidelines Chapter F.13: PIC/S PI 037-1 Recommendation: A Recommended Model for Risk-based Inspection Planning in the GMP Environment
  
  • F.14: PIC/S PI 038-1 Aide-mémoire: Assessment Of Quality Risk Management Implementation
  • F.15: Questions & Answers Document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs) Chapter F.16: PIC/S PI 030-1 Aide-mémoire: Inspection of Active Pharmaceutical Ingredients

Updated Chapters:

• E: ICH Guidelines
  
  • E.10.1: Quality Implementation Working Group on Q8, Q9 and Q10: Questions & Answers (R4)

The recent update of the GMP MANUAL (October 2012) encompasses approx. 860 pages for the print version and 50 additional pages for the CD and online versions.

The contents of Update 14 are outlined below:

“GMP in Practice"

New Chapters:

• Chapter 12: Sterile Production
  
  • 12.H Testing for Endotoxins

• Chapter 19: Quality Unit
  
  • 19.D Corrective and preventive actions (CAPA)

Updated Chapters:

• Chapter 12: Sterile Production
  
  • 12.F: Freeze drying / Lyophilization (formerly 12.J)
  • 12.G: Testing for sterility (formerly 12.H)
  • 12.I: Testing for tightness and particles
  • 12.J: Microbiological monitoring (formerly 12.G)
  • 12.K: References

• Chapter 15: Documentation
  
  • 15.A: Official requirements
  • 15.G: References

• Chapter 18: Inspections
  
  • 18.H: Questionnaire for preparing GMP-inspections

• Chapter 19: Quality Unit
  
  • 19.C: Change Management (formerly Change Control)
  • 19.E: References (formerly 19.D)

“GMP Regulations”

New Chapters:

• Chapter C: EU Directives and Guidelines
  
  • C.8.5: New Rules on Importing Active Pharmaceutical Ingredients
    into the European Union
  • C.8.5.1: Importation of Active Substances for Medicinal Products
    for Human Use Questions and Answers
  • C.13: Guideline on Real Time Release Testing

• Chapter D: USA: CFR and FDA Guidelines
  
  • D.13: Incorporation of Physical-Chemical Identifiers into Solid Oral
    Dosage Form Drug Products for Anticounterfeiting

• Chapter E: ICH Guidelines
  
  • E.7: ICH Q7 / APIC How-to-do Document

• Chapter G: GMP of other Regions
  
  • G.1.4: WHO TRS 961 (2011), Annex 9: Model Guidance for the Storage
    and Transport of Time- and Temperature-sensitive Pharmaceutical
    Products (online only)

Updated Chapters:

• Chapter C: EU Directives and Guidelines
  
  • C.4.1: EU GMP Guide Part I, Chapter 1
  • C.4.7: EU GMP Guide Part I, Chapter 7
  • C.6.2: EU GMP Guide Annex 2

• Chapter D: USA: CFR and FDA Guidelines
  
  • D.1.1: 21 CFR Part 210
  • D.1.2: 21 CFR Part 211
  • D.1.3: 21 CFR Part 11
  • D.1.4: 21 CFR Part 820 (formerly chapter D.13)

The recent update of the GMP MANUAL encompasses approx. 590 pages for the print version and nearly 300 additional pages for the CD and online versions.
Due to the continuous expansion of the contents of the GMP MANUAL – currently the inclusion of the extensive directive 2001/83/EC (“Pharma-Directive”) – we faced the necessity to introduce a new file for the “GMP Regulations” part. You will find a detailed description of the change procedure for the files in the update instruction (printed version only).

The contents of Update 13 are outlined below:

“GMP in Practice"

New Chapters:

• Chapter 12: Sterile Production
  
  • Chapter 12.A: Introduction
  • Chapter 12.C: Manufacture of terminally sterilised products
  • Chapter 12.D: Sterilisation processes
  • Chapter 12.E: Aseptic processing
  • Chapter 12.K: References

• Chapter 16: Research and Development
  
  • Chapter 16.G: Quality by Design
  • Chapter 16.H: References

• Chapter 18: Inspections
  
  • Chapter 18.I: Inspection of API manufacturers

Updated Chapters:

• Chapter 12: Sterile Production
  
  • Chapter 12.B: Airlock concepts

• Chapter 18: Inspections
  
  • Chapter 18.J: References

“GMP Regulations”

New Chapters:

• Chapter C: EU Directives and Guidelines
  
  • C.12: EU Directive 2001/83/EC

• Chapter F: PIC/S Guidelines
  
  • F.9: PIC/S PE 009-9 (GMP Guide): Introduction
  • F.10: PIC/S PE 009-9 (GMP Guide): Part I
  • F.11: PIC/S PE 009-9 (GMP Guide): Part II
  • F.12: PIC/S PE 009-9 (GMP Guide): Annexes

• Chapter G: GMP of other regions (CD and online only):
  
  • G.4: Chinese GMP

Updated Chapters:

• Chapter G: GMP of other regions (CD and online only):
  
  • G.2: Canadian Regulations

• Chapter H: Information:
  
  • H.4: References

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

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

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

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