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TOP 5 GMP Downloads

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

 

2. GMP Audit Checklist
Great for both sides - the auditor and the inspected company.

 

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

 

4. Industry Guide to handle OOX Test Results
A concise overview of the OOX process.

 

5. GMP-Questionnaire: Contract manufacturing / Contract analysis
Standard draft to adapt and extend.

 

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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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GMP LOGFILE Features

2016-02-10

Process Validation – How do I implement the new GMP requirements?

Results of the GMP Conference in 2015

Report by Dr. Sabine Paris

 
2016-02-03

Deviations – Definition and Requirements

An excerpt from GMP Series Implementing a World Class Deviation Management

By Dr. Christian Gausepohl

 
2016-01-27

Possible risks of manufacturing and packaging

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein

 
2016-01-20

Intermediate bulk container systems

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

An excerpt from the GMP MANUAL

by Richard Denk

 
2016-01-13

2016 – GMP in Production

by Thomas Peither

 
2015-12-16

Managing Outsourced GMP Activities Successfully

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher and Dr. jur. Ingo Schneider

 
2015-12-09

How do you transport and store medicinal products?

Here is what you have to know!

by Dr. Sabine Paris

 
2015-11-24

Reasons for Outsourcing

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher

 
2015-11-18

Organization of Audits

An excerpt of the GMP-Audit-Checklist

by Dr. Michael Hiob and Max Lazar

 
2015-11-12

Particle Monitoring

An excerpt from the GMP MANUAL

by Thomas von Kahlden

 
2015-11-05

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

 
2015-10-30

Checklist Performance Qualification

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

by Dr. Hans H. Schicht

 
2015-10-21

The purpose of GMP

An excerpt of GMP Fundamentals

by Dr. Christine Oechslein

 
2015-10-15

Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Stefan Kettelhoit

 
2015-10-07

Roadmap to Manage Personnel in Pharmaceutical Manufacturing

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Michael Hiob

 
 
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