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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 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

2017-05-24

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

 
2017-04-12

170 Questions You Should Ask Your Supplier

An excerpt from the GMP Series GMP Supplier Assessment Questionnaire

3 min. reading time

by Cornelia Wawretschek

 
2017-04-05

“Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)”

A comment by Fritz Röder and Ruven Brandes

(reading time 5 min)

by Fritz Röder and Ruven Brandes

 
2017-03-29

Document Access for GMP Inspectors and Auditors of Notified Bodies

Your question – our answer – Part 2

(5 min. reading time)

by Dr. Sabine Paris

 
2017-03-22

24 GMP documents You Should Know About–

A Concise Review of Everything New in 2016

by Sabine Rabus

 
2017-03-15

What do GMP compliance and GEP mean?

An excerpt from the GMP Compliance Adviser

(4 min. reading time)

by Thomas Peither

 
2017-03-08

Temperature monitoring and control

An excerpt from the GMP Series The Process of Freeze-Drying

(3 min. reading time)

by Dr. Margit Gieseler

 
2017-03-01

Self-Inspection Q&A

(4 min. reading time)

by Dr. Doris Borchert and Dr. Sabine Paris

 
2017-02-22

Executing Sterile Filtration

An excerpt from the GMP Series download Aseptic Processing of Sterile Medicinal Products

by Ruven Brandes

 
2017-02-15

How do you create awareness for GMP compliance in a ­company?

An excerpt from the GMP MANUAL, Chapter 18.I.4.1

(3 min. reading time)

by Thomas Peither

 
 
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