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GMP MANUAL

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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

2016-09-05

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

5.D
Qualification of water supply systems
6.A

Official requirements and agency expectations

6.B
Activities for the preparation of a qualification
6.H
The qualification lifecycle (NEW)
6.I
Validation by third party (NEW)
8.E
Establishment of limits
18.H Questionnaire for preparing GMP-inspections


GMP Regulations

D.1.1 CFR 210
D.1.2
CFR 211
D.1.3
CFR 11
D.1.4
CFR 820
D.1.5
CFR 4
H.8
WHO GMP practices for biological products, WHO TRS No. 996, 2016
H.11 WHO Guideline on GMP: validation, Appendix 7: non-sterile process validation Annex 3, WHO TRS 992, 2015
H.17 WHO Guidance on good data and record management practices
 
2016-06-19

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

5.F Pure Steam Systems
5.G
Monitoring Pharmaceutical Water
7.B
Validation – a key element in a QM system
7.C
Organisation, planning and implementation
14.A
Sampling
17.B
Contract Analysis


GMP Regulations

C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use Q&A Version 6
D.1.8
21 CFR 680
D.1.9
21 CFR 601
D.20
Quality Considerations in Demonstrating Biosimilarity
D.21
Biosimilars: Q&A
D.22
Data Integrity and Compliance with CGMP, DRAFT
 
2016-03-21

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.H Pharmaceutical gases
11.H
Labelling
11.I
In-Process controls
11.K
Rework
14.I
Documentation in the laboratory
14.K
Microbiological testing
19.L Management review
24.A
Storage
24.B
Storage areas
24.C
Storage conditions
24.D Incoming goods


GMP Regulations

C.6.16 Annex 16: Certification by a
Qualified Person and Batch Release
C.6.17.1 Annex 17 Draft: Real Time Release Testing
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 600
D.1.7 21 CFR Part 606
D.19 Guidance for Industry: Scientific Considerations in
Demonstrating Biosimilarity to a Reference Product
 
2015-10-18

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.A Official requirements
5.C
Distribution and storage of pharmaceutical water
5.E
Operation of water supplies
11.F GMP in the production process
11.J Prevention of cross-contamination
14.G Stability Testing

GMP Regulations

C.5 EU GMP Guidelines, Part II – combined with APIC How to do (Version August 2015)
C.20 Guidelines on Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use
E.7.1 ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – Questions and Answers
H.11 Supplementary Guidelines on GMP: Validation, Appendix 7: Non-sterile Process Validation (TRS No. 986, 2014)
H.15.1
Technical Supplements to Model Guidance for the Storage and Transport of Time- and Temperature-sensitive Pharmaceutical Products (TRS No. 992, 2015, Annex 5 und 11 Supplements)
H.16 General Guidance on Hold-time Studies (TRS No. 992, 2015, Annex 4)
 
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
 
 
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