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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?

 

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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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The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

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GMP LOGFILE Features

2017-07-26

What you can expect from the newly amended MRA between the EU and the USA – Facts and figures in the GMP Sector – Part 1

5 minutes reading time

by Sabine Paris, PhD

 
2017-07-19

Checklist Performance Qualification

An Excerpt from the GMP Series PDF Download The Ultimate Checklist for Premises and HVAC Qualification

by Hans H. Schicht, PhD

 
2017-07-12

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

 
2017-07-05

Types of Biotechnological Active Substances

An excerpt from GMP Series Managing GMP Requirements in Biotech API Manufacturing

by Dr. Rainer Gnibl

 
2017-06-28

Manufacturing Innovation -
PDA Annual Meeting 2017, Anaheim

8 min. reading time

by Thomas Peither

 
2017-06-21

Test results outside defined criteria (OOX)

An excerpt of the GMP Series Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger

 
2017-06-14

Changes in USP <1231>: Water for Pharmaceutical Purposes

8 min. reading time

by Fritz Röder

 
2017-06-07

Independent and Linked CAPA Systems

An excerpt from the GMP Series How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment

3 min. reading time

by Dr. Bernd Renger

 
2017-05-31

Quality Agreement – A Sample Document

An excerpt from the GMP Series Quality Agreement

by Dr. Christine Oechslein

 
2017-05-24

85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

by Dr. Christine Oechslein

 
2017-05-17

A Challenge: Complex Product and Process Flows

An excerpt from the GMP Compliance Adviser (formerly GMP MANUAL), Chapter 14.J.8 and 14.J.8.1

3 min. reading time

by Rainer Gnibl

 
2017-05-10

Data Integrity is a Must!

5 min. reading time

A contribution from Thomas Peither

 
2017-05-03

Chemical Active Substances – Special Risks

An excerpt from the GMP Series Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

4 min. reading time

by Stefan Kettelhoit, PhD

 
2017-04-26

130 Elements You Need for a World-Class Technical Agreement

by Dr. Christine Oechslein

 
2017-04-19

Formalizing a Risk Assessment for Excipients

by Frithjof Holtz

 
 
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