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


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


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


4. Industry Guide to handle OOX Test Results
Every single step of the OOX process.


5. The New USP <1231>: Water for Pharmaceutical Purposes
A compact overview of the contents of the new version of USP <1231>.


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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

2018-02-21

What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1

6 minutes reading time

A commentary by Ruven Brandes and Fritz Röder

 
2018-02-14

Root Cause Analysis – An Essential Enabler

An excerpt from the GMP Compliance Adviser, Chapter 20.E Failure Management

8 minutes reading time

by Martin Mayer

 
2018-02-07

Implementing and Monitoring Data Integrity Measures

An excerpt from the GMP Focus PDF Download Data Integrity in the EU

5 minutes reading time

by Markus Veit, PhD

 
2018-01-31

Key learnings from serialisation projects – Part 2

6 minutes reading time

by Andrew Love and Stephen McIndoe

 
2018-01-24

Key learnings from serialisation projects – Part 1

6 minutes reading time

by Andrew Love and Stephen McIndoe

 
2018-01-17

Risk Analysis in the Equipment Life Cycle

An excerpt from the GMP Focus PDF Download Principles of Equipment Qualification

5 minutes reading time

by Ulrike Reuter

 
2018-01-10

Ask Our Experts – Part 2

4 GMP-Questions which might be of your interest

7 minutes reading time

by Sabine Rabus

 
2017-12-13

Ask Our Experts – Part 1

6 GMP-Questions which might be of interest to you

7 minutes reading time

by Sabine Rabus

 
2017-12-06

International GMP – Six Questions for Jacques Morénas

5 minutes reading time

 

 
2017-11-29

8 Golden Rules for Personnel Hygiene

An excerpt from the GMP Compliance Adviser, Chapter 11.B.5

4 minutes reading time

by Christian Gausepohl, PhD

 
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

 
 
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