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1. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.

 

2. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.

 

3. GDP Audit Checklist
More than 700 questions with reference to regulations.

 

4. The New USP <1231>: Water for Pharmaceutical Purposes
A detailed overview

 

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GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

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The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

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GMP LOGFILE Features

2017-11-22

Intermediate Bulk Container Systems

An excerpt from the GMP Series PDF Download Technical Solutions for Personal Protection in Solid Drug Manufacturing

5 minutes reading time

by Richard Denk

 
2017-11-15

Indispensable: The Determination of PDE Values as Exposure Limits for Risk Analysis in Shared Facilities

It is not possible to estimate the danger or toxicity of APIs only according to their therapeutic group.
Results of an analysis of 1200 active substances.

8 minutes reading time

by Beatriz Carrero, PhD, Azierta and Sabine Paris, PhD, Maas & Peither – GMP Publishing

 
2017-11-08

Update: Final version of the EMA Q&A paper on WFI production without distillation

5 minutes reading time

by Fritz Röder

 
2017-11-01

Deviations – Definition and Requirements

An excerpt from GMP Series Implementing a World Class Deviation Management

By Dr. Christian Gausepohl

 
2017-10-25

Calibration of laboratory instruments

An excerpt of the GMP Compliance Adviser, Chapter 14.D.4

5 minutes reading time

by Josef Künzle, PhD, Wolfgang Nedvidek, PhD

 
2017-10-18

Mobile water treatment possible even in the GMP area for the first time!

6 minutes reading time

by Fritz Röder

 
2017-10-11

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

6 minutes reading time

by Dr. Tim Sandle

 
2017-10-05

Physical monitoring of cleanrooms

An excerpt from GMP Series Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht

 
2017-09-27

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

6 minutes reading time

by Dr. Tim Sandle

 
2017-09-20

Technology Transfer Phases

An excerpt from GMP Series A Successful Concept for Technology Transfer in Drug Manufacturing

5 minutes reading time

by Christian Gausepohl, PhD

 
2017-09-13

Data Integrity – Old Wine in New Skins?
GMP Talk Between the GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 2

Data Integrity – Old Wine in New Skins?

GMP Talk Between the GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 2

7 minutes reading time

by Sabine Paris, PhD

 
2017-09-06

Data Integrity – Old Wine in New Skins?

GMP-Talk Between GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 1

7 minutes reading time

by Sabine Paris, PhD

 
2017-08-30

Human Resource Management: Qualification requirements and requirement profiles

An Excerpt from the GMP Series PDF Download Roadmap to Manage Personnel in Pharmaceutical Manufacturing

by Michael Hiob, PhD

 
2017-08-23

GMP-Compliance-Index 2017

Join in now and further your knowledge!

by Thomas Peither

 
2017-08-02

What you can expect from the newly amended MRA between the EU and the USA – Facts and figures in the GMP Sector – Part 2

5 minutes reading time

by Sabine Paris, PhD

 
 
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