• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

TOP 5 GMP Downloads

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

 

5. GMP Compliance Basics of Packaging Materials and Processes
Are you on top of the best practices you need to design and create your packaging correctly — every time?

 

>>> More Downloads

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.

 

Image

>>> READ MORE

Award
Image
The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

>>> ORDER NOW

GMP LOGFILE Features

2017-01-25

Limit Values for Cleaning Processes:
Implementing Toxicological Risk Assessment – Part 2

(5 min. reading time)

by Dr. Sabine Paris

 
2017-01-18

Limit Values for Cleaning Processes:
Implementing Toxicological Risk Assessment – Part 1

(5 min. reading time)

by Dr. Sabine Paris

 

 
2017-01-11

Alert and action levels and specifications

An excerpt from the USP <1231> Download

by Fritz Röder

 
2016-12-14

Quality Metrics – What will the FDA require in the future? How are companies already benefitting today?

(5 min. reading time)

by Dr. Sabine Paris

 
2016-12-07

Rework: What has to be observed?

An excerpt from the GMP MANUAL

by Dr. Christian Gausepohl

 
2016-11-29

Managing Contract Manufacturers and Testing Labs

An excerpt from the GMP Focus download Managing Contract Manufacturers and Testing Labs

by Dr. Christian Gausepohl, Dr. Frank Böttcher

 
2016-11-22

Line Clearance

An excerpt from the GMP Series download GMP Compliance Basics of Packaging Materials and Processes

by Ruven Brandes, Dr. Christian Gausepohl

 
2016-11-16

Transport Validation

An excerpt from the GMP Focus download Creating a Master Plan for Drug Warehousing, Transportation and Distribution

by Dr. Christoph Frick, Dr. Nicola Spiggelkötter

 
2016-11-09

The qualification life cycle concept and tools: an overview

An excerpt from the GMP MANUAL

by Ulrike Reuter

 
2016-10-20

Validation Planning

An excerpt from the GMP Focus download Managing Process Validation: A Drugmaker's Guide

by Dr. Christine Oechslein

 
2016-10-12

Evolution and a Touch of GMP Revolution at the PDA/FDA JRC 2016

(Reading time 5 min + 3 min video)

by Thomas Peither

 
2016-10-05

Self-Inspection

An excerpt from the GMP Focus PDF Download Preparing for the EU GMP Inspection

by Dr. Christian Gausepohl and Max Lazar

 
2016-09-28

Not yet all clear: Draft EMA Q&A paper on production of WFI by non-distillation methods

An interview with Fritz Röder

 
2016-09-21

Receiving the OOS result and starting the OOS process

An Excerpt from the GMP Series PDF Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger

 
2016-09-14

The changing concept of validation

An excerpt from the GMP MANUAL

by Dr. Christine Oechslein

 
 
Page 1/11    1   2   3   4   5   6   7   8   9   10