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Customers Opinion

Recommended by PDA (Parenteral Drug Association):

 

"... The GMP MANUAL occupies a spot in my bookcase and I often have the occasion to refer to it. If you are a professional in the field of GMP and regulatory compliance, you may find it should be in your bookcase too."

Bob Dana, Sen. VP Regulatory Affairs

 

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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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Reading Samples

See for yourself how GMP MANUAL provides you with state-of-the art GMP know-how that will simplify your daily business!

 

Table of contents

>>> full table of contents

 

Reading Samples
"GMP in Practice"

1.B The road to a pharmaceutical quality system

 

Extract: 7.A Process Validation - Official Requirements

 

Extract: 18.H Questionnaire for preparing GMP inspections

 

19.B.3 The qualified person - Qualification and Experience

 

21.A.11 GMP for APIs - Laboratory Controls

 

10 valuable reasons to buy the GMP MANUAL

#1 Benchmark your procedures

It´s important to know how other experts solved the quality challenge in their company. With that knowledge you can improve and fine-tune your procedures and processes.

#2 Regulations and Interpretations in One Convenient Source

You need complete GMP information in one easy location. Are you wasting time looking at several websites to gather the information you need? We do that for you and cover regulations and the interpretations all at one source, with one search engine to save you time & money.

#3 The only current GMP knowledge source that has THE AUTHORITY

As you know, only the most current information is good information. We update the GMP MANUAL on a regular basis. Our knowledge source remains up-to-date.

#4 More than 10,000 satisfied users around the globe

We realize that you are looking for a knowledge source that is accepted by the industry and regulators. The GMP MANUAL is used in more than 65 countries around the globe. More than 10,000 professionals must be right. They all save time & money by using the GMP MANUAL knowledge source.

#5 Training Material

If you have to prepare presentations and training programs, do you need training/reference material for new employees? The GMP MANUAL’s 21 Chapters cover nearly every topic in the area of GMP. Clear description - easy to understand – a must have and beneficial for your business.

#6 Global perspective of cGMP

You get information from the most important GMP regions: Europe, USA, Japan. We deliver information about globally implemented GMP procedures that will fulfil all GMP requirements. Be sure to follow the best practices outlined in The GMP MANUAL.

#7 It’s easy to find the appropriate information when needed

You will find it an easy and efficient way to retrieve the appropriate information needed. We implemented a powerful search engine, a comprehensive index and one table of contents. Don’t spend time searching – find what you need quickly!

#8 Recommended by leading industry associations

The PDA (Parenteral Drug Association) recommend the GMP MANUAL to their members. Review the GMP MANUAL accurately and you will find it very helpful for your business.

#9 Reliable information that is peer-reviewed with US and EU experts

You need GMP information that is reviewed by experts and is guaranteed reliable. Our advisory board includes members from US, Europe and Japan. They supervise the content and development of the GMP MANUAL. More than 50 experts around the world write articles that are peer-reviewed. You get the best GMP information when you need it.

#10 Paper, CD-ROM or Online

You want flexibility in using the GMP information? We have the solution for every requirement. If you want to use a paper version, a CD-ROM for travelling or an online version, we have the appropriate solution for your needs.

>>>more information: GMP MANUAL

and some more reasons ...

#11 You get answers to quality related questions for doing business daily

You are looking for usable procedures and GMP information that will improve your documentations, procedures and presentations. With the GMP MANUAL you find this knowledge in one source.

#12 Most comprehensive cGMP knowledge source

You know that GMP requirements cover many different aspects in a multitude of departments. The GMP MANUAL is the most comprehensive collection of interpretations in one source with approx. 4,000 pages of certified content.

#13 Save time & money

You often need GMP information quickly and you have no time to loose. With the GMP MANUAL you have all the information in one source. Find what you need – when you need it!

#14 Global advisory board

You need certified GMP information. The global advisory board with 19 experts from every important region (US, Europe, Japan) supervises the development of the GMP MANUAL. It is your portal to the global network.

#15 Easy corporate access

You need a system that is easy to access, use and handle? All employees in a company can use the GMP database without registering and we have one fee for the whole company – worldwide.

#16 Clean up your bookcase

Do you know which books, in your bookcase have the appropriate information needed—are they current and complete? The GMP MANUAL covers more than 20 books -- in one source -- with one search engine, one index, and one table of contents.

>>>more information: GMP MANUAL