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GMP Compliance Adviser

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On 7 June 2016 Maas & Peither GMP Publishing has received a

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The GMP MANUAL (now: GMP Compliance Adviser) impressed the jury with "Save Drugs through Better GMP Understanding".


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GMP Compliance Adviser (formerly 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

2017-07-27

With this GMP Compliance Adviser 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

8.A
Official requirements and agency expectations


GMP Regulations

C.5
EU GMP Guide Part II:
Basic Requirements for Active Substances used as Starting Materials
combined with GMP for APIs:
“How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide

 
2017-06-23

With this GMP Compliance Adviser 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 Regulations

C.10
Compilation of Community Procedures on Inspections and Exchange of Information
C.10.1

Conduct of Inspections of Pharmaceutical Manufacturers or Importers

C.10.2 Outline of a Procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries
C.10.3 Guideline on Training and Qualifications of GMP Inspectors
C.10.4 Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials
C.10.5 The Issue and Update of GMP Certificates
C.10.6 A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers
C.10.7 Procedure for dealing with serious GMP non-compliance requiring co-ordinated measures to protect public or animal health
C.10.8 Procedure for Dealing with Serious GMP Non-Compliance Information Originating from Third Country Authorities or International Organisations
C.10.9 Guideline on Training and Qualification of Inspectors Performing Inspections of Wholesale Distributors
C.10.10 GDP Inspection Procedure (Medicinal Products for Human Use)
C.10.11 The Issue and Update of GDP Certificates (Medicinal Products for Human Use)

 
2017-05-12

With this GMP Compliance Adviser 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

6.J
Example SOP for the qualification
of equipment and machinery
14.N

Data integrity in the quality control
laboratory

15.H Data integrity - general requirements
in a GxP-regulated environment

 
2017-04-12

With this GMP Compliance Adviser 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

6.E
Installation Qualification (IQ)
14.J

Batch Release


GMP Regulations

D.1.5
21 CFR Part 4 Regulation of Combination Products
D.25
Guidance for Industry and FDA Staff:
Current Good Manufacturing Practice Requirements for Combination Products

 
2017-02-28

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

4.A
Facility Planning
4.B

Materials

13.A.8 Packaging material testing


GMP Regulations

D.24
Guidance for Industry:
Contract Manufacturing Arrangements for Drugs: Quality Agreements
H.18
WHO: Good trade and distribution practices for pharmaceutical starting materials
(Technical Report Series, No. 996 (2016), Annex 6)

 
2017-02-01

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

6.D
Design Qualification (DQ)
18.I

Preparing for FDA GMP inspections


GMP Regulations

C.21
EMA: Data Integrity Questions and Answers
E.3.C
ICH Q3C(R6): Impurities: Guideline for Residual Solvents

 
2016-12-01

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.F
Building Services
6.C

Qualification documentation

7.A
Official requirements and agency expectations
7.D
Validation documentation
9.H
Validation of Excel applications
11.G
Weighing
18.F Self-inspection


GMP Regulations

C.8.5.1
Importation of Active Substances for Medicinal Products for Human Use, Q&A, Version 7
D.1.6 21
CFR 600
D.1.7 21
CFR 606
D.1.8 21
CFR 680
D.1.9 21
CFR 601
D.23
Submission of Quality Metrics Data, Revision 1, DRAFT
D.23.1 Quality Metrics Technical Conformance Guide, Version 1.0, DRAFT

 
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

 
 
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