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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

2015-07-27

With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

3.B Material flow, personnel flow and layout
3.I Qualification of premises and air-conditioning (HVAC) systems
3.K Particle Monitoring (NEW)
5.A Water qualities
5.B Generation of pharmaceutical water
14.B Substances used in laboratories (NEW, replaces former 14.B and 14.C)
17.A Contract manufacture

GMP Regulations

C.5 EU GMP Guidelines, Part II – combined with APIC How to do-Guide on
ICH Q7
C.6.15 Annex 15: Qualification and Validation
C.8.5.1 Importation of Active Substances for Medicinal Products for Human
Use – Questions and Answers, Version 5.1
C.8.6 NUMBERING MODIFICATION from C.19 to C.8.6
C.8.7 Guidelines on the formalised risk assessment for ascertaining the appropriate
good manufacturing practice for excipients of medicinal
products for human use
C.19 Reflection paper on the requirements for selection and justification of
starting materials for the manufacture of chemical active substances
 
2015-03-26

With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

 

GMP in Practice

3.C

Air cleanliness classes and grades

3.E

Barrier systems, isolators and safety cabinets

4.C

Hygienic Design in solids handling

4.I

Containment in solids handling

13.A

Packaging materials (new author)

19.J

Coding and serialisation of folding cartons

19.K

Outsourced activities

 

GMP Regulations

C.4.3

Chapter 3 Premises and equipment

C.4.5

Chapter 5 Production

C.6.1.1

Concept paper on the revision of annex 1 – manufacture of sterile medicinal products

C.12.1

Commission delegated regulation (EU) No 1252/2014 supplementing Directive 2001/83/EC for active substances for medicinal products for human use

C.19

EMA: Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

D.1.5.1

FDA: Current good manufacturing practice requirements for combination products – Draft guidance

E.3.D

ICH Q3D: Guideline for elemental impurities

E.12

ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management – Final concept paper

 
2015-01-07

What is new?

GMP in Practice

New Chapters:

  • Chapter 3 Premises
    • Chapter 3.J.6 Validation of a monitoring system in accordance with GAMP5
  • Chapter 13 Packaging
    • Chapter 13.D Blow-fill-seal technology (BFS technology)
  • Chapter 21 Active Pharmaceutical Ingredients
    • Chapter 21.G Biotechnological active substances

Updated Chapters:

  • Chapter 3 Premises
    • Chapter 3.J Pharma monitoring of HVAC systems
  • Chapter 14 Laboratory controls
    • Chapter 14.H Test Results outside defined criteria (OOX)

GMP Regulations

New Chapters:

  • Chapter C EU Directives and Guidelines
    • C.16 Directive 2009/41/EC on the contained use of genetically modified micro-organisms
    • C.17 Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work
  • Chapter F PIC/S Guidelines
    • F.25 PIC/S PE 011-1 Guide to GDP for Medicinal Products
  • Chapter H WHO Guidelines
    • H.3 Guidelines on Quality Risk Management
    • H.6 Guide on transfer of technology in pharmaceutical manufacturing

Updated Chapters:

  • Chapter A Information
    • A.2 GMP Abbreviations
    • A.3 GMP Glossary
  • Chapter H WHO Guidelines
    • H.1 GMPs for pharmaceutical products: main principles
    • H.2 GMPs for active pharmaceutical ingredients
    • H.4 Water for pharmaceutical use
    • H.5 GMPS for sterile pharmaceutical products
 
2014-10-09

What is new?

GMP in Practice

New Chapters:

  • Chapter 4 Facilities and Equipment
    • 4.A: Facility Planning
    • 4.B: Materials
    • 4.H: Cleaning of Facilities

Updated Chapters:

  • Chapter 4 Facilities and Equipment
    • 4.C Hygienic Design in Solids Handling (formerly 4.L, still under revision)
    • 4.D System Controllers and Process Control Systems (formerly 4.C and 4.K)
    • 4.E Technical Documentation (formerly 4.F)
    • 4.F Calibration (formerly 4.G)
    • 4.G Maintenance (formerly 4.H)
    • 4.I Containment (personnel protection) in Solids Handling
      (formerly 4.J, still under revision)

GMP Regulations

New Chapters:

  • Chapter C EU Directives and Guidelines
    • C.18 Guidance for the template for the qualified person’s declaration concerning GMP compliance of active substance manufacture “The QP declaration template”
    • C.18.1 Qualified Person’s declaration concerning GMP compliance of the active substance manufacture “The QP declaration template”

Updated Chapters:

  • Chapter C EU Directives and Guidelines
    • C.4 Part I Basic Requirements for Medicinal Products
      C.4.3.1 Chapter 3 Premises and Equipment (entry into force 1 March 2015)
      C.4.5.1 Chapter 5 Production (entry into force 1 March 2015)
      C.4.8.1 Chapter 8 Complaints, Quality Defects and Products (entry into force 1 March 2015)
      C.5 Part II Basic Requirements for Active Substances used as Starting Materials
      C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use – Questions and Answers Version 5.0
  • Chapter D.1 Code of Federal Regulations
    • 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
    • D.1.5 21 CFR Part 4
    • D.1.6 21 CFR Part 606
    • D.1.7 21 CFR Part 606
  • Chapter F PIC/S Guidelines
    • F.9 PIC/S PE 009-11 GMP Guide Introduction
    • F.10 PIC/S PE 009-11 GMP Guide Part I
    • F.11 PIC/S PE 009-11 GMP Guide Part II
    • F.12 PIC/S PE 009-11 GMP Guide Annexes

 
2014-06-12

What is new?

GMP in Practice

New Chapters:

  • Chapter 2 Personnel
    • Chapter 2.A Human Resource Management
    • Chapter 2.B Health Monitoring and Occupational Health and Safety
  • Chapter 19. Quality Unit
    • Chapter 19.A Quality Assurance Duties
  • Chapter 10 Quality Risk Management (formerly Considerations on Risk Management, completely new version)

Updated Chapters:

  • Chapter 2 Personnel
    • Chapter 2.C Training

GMP Regulations

New Chapters:

  • Chapter C EU Directives and Guidelines
    • C.4.3.1 EU-GMP Guide Part I, Draft Chapter 3 Premises and Equipment
    • C.4.5.1 EU-GMP Guide Part I, Draft Chapter 5 Production
    • C.4.8.1 EU-GMP Guide Part I, Draft Chapter 8 Complaints, Quality Defects and Product Recalls
    • C.6.15.1 EU-GMP Guide Part I, Draft Annex 15 Qualification and Validation
    • C.6.16.1 EU-GMP Guide Part I, Draft Annex 16 Certification by a Qualified Person and Batch Release
    • C.14.1 Good Distribution Practice for Medicinal Products for Human Use Questions and Answers
    • C.17 Guideline on Process Validation for Finished Products – Information and Data to be Provided in Regulatory Submissions
  • Chapter D CFR and FDA Guidelines
    • D.6 Pharmaceutical CGMPs for the 21st Century – A Risk Based Approach
    • D.7 General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Updated Chapters:

  • Chapter C EU Directives and Guidelines
    • C.4.6 EU GMP Guide Part I, Chapter 6 Quality Control
 
2014-03-13

The content of Update No.17 is outlined below:

GMP in Practice

New Chapters:

  • 13.C Qualification of a servo-controlled blister packaging line
  • 21. Active Pharmaceutical Ingredients (completely new version)

Updated Chapters:

  • 13.B Packaging Process
  • 13.D References
  • 15.B GMP-compliant Documentation

GMP Regulations

New Chapters:

  • Chapter D: CFR and FDA Guidelines
    • D.1.5: 21 CFR Part 4 – Regulation of Combination Products
    • D.1.6: 21 CFR Part 600 – Biological Products: General
    • D.1.7: 21 CFR Part 606 – cGMP for Blood and Blood Components
  • Chapter F: PIC/S Guidelines
    • F.22: PIC/S PE 010-4 – Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
    • F.23: PIC/S PI 021-2 – GMP Particularities in the Manufacture of Medicinal Products to be Used in Clinical Trials on Human Subjects

Updated Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.4.2: EU GMP Guidelines, Chapter 2 Personnel
    • C.14: Guidelines on Good Distribution Practice of Medicinal Products for Human Use
  • Chapter G: GMP of other Regions
    • G.2.2.7: Canadian Regulations, Annex 14 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule D Drugs, Human Blood and Blood Components (GUI-0032)
  • Chapter H: Information
    • H.3: Addresses
 
2013-09-29
 
2013-09-13

Dr. Christoph Frick and Dr. Nicola Spiggelkötter have written the following new chapter to our GMP MANUAL:

GMP in Practice

  • Chapter 24 Transport (completely new version, replaces chapter 11.N Transportation)
 
2013-04-02

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)
 
2012-10-12

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)
 
2012-03-08

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
 
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

 
 
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