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Award for the
GMP Compliance Adviser

GMP knowledge that convinces.

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

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

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


KNOWLEDGE IS POWER!

The GMP Compliance Adviser is the most powerful and dependable reference tool in the world.

Indispensable for

  • pharmaceutical manufacturers,
  • suppliers,
  • consultants and
  • engineering companies
that need the most updated information available.

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the GMP Compliance Adviser.


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GMP Compliance Adviser

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

2018-04-18

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

3.I
Air Handling Technology

 
2018-03-06

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.F
Operational Qualification (OQ)
6.G Performance Qualification (PQ)


GMP Regulations

E.12
Draft Version ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

 
2018-02-06

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.6.1.1
Annex 1 – Draft: Manufacture of Sterile Medicinal Products
C.22 Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
D.26 Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

 
2017-12-18

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

11.C
Production hygiene
11.D Hygiene plan

 
2017-11-16

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

11.A
Industrial Hygiene
11.B Personnel Hygiene

 
2017-10-13

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

14.D
Laboratory Instruments


GMP Regulations

E.11.1
ICH Q11: Q&A
Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

 
2017-09-15

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

20.E
Failure Management


GMP Regulations

GMP Glossary
updated
D.1.1

21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

D.1.2 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
D.1.3 21 CFR Part 11 Electronic Records; Electronic Signatures
D.1.4 21 CFR Part 820 Quality System Regulation
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 Current Good Manufacturing Practice for Blood and Blood Components
D.1.8 21 CFR Part 680 Additional Standards for Miscellaneous Products
D.1.9 21 CFR Part 601 Licensing

 
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
 
 
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