Equipment Qualification DQ & IQ

Equipment Qualification Part II DQ & IQ

In the last issue of the LOGFILE we startet with part I of the qualification series. Today you can download part II with the official requirements of design and installation qualification. Read what regulators say about these topics.

Qualification Part II (DQ & IQ)

You missed part I? Get it here ...

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• write your opinion about the issue
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Comprehensive GMP Glossary

You will find now on our website gmp-publishing.com a very comprehensive GMP Glossary with more than 500 definitions of the most important technical terms. Check it out and send us an e-mail if you miss any definitions.

Click here for the GMP Glossary

Pre-order now: GMP MANUAL Volume 2 Validation Procedures

Volume 1 Manufacturing is a success on the market. Now we prepare the publication of Volume 2: Validation Procedures. In this book you will find the following contents:

• Qualification
• Process Validation
• Cleaning Validation
• Computer Validation

Table of contents:

TOC-Volume2-ValidationProcedures.pdf

Order now Volume 2 Validation Procedures....

GMP-Survey: Quality Management Systems

Please participate in the brief survey below about quality management systems (2 minutes max!).

GMP Survey Quality Management Systems

The last survey about equipment qualification delivered some interesting results. E.g. 47% of the participants still perform retrospective qualifications. Read more in the results.

LOGFILE-Results-Equipment-Qualification.pdf

PDA publications are now available in our web shop

Since 2007 PDA (Parenteral Drug Association) and Maas & Peither are cultivating a growing partnership. As an European partner we are now also selling selected books of the PDA/DHI Publications. Have a look at our website: international books.

Today we introduce you to:

• Chinese Drug GMP
• Risk-Based Compliance Handbook
• Filtration Handbook Series

Order directly in our convenient and secure web shop.

Pharmaceutical Technology cooperates with Maas & Peither

Pharmaceutical Technology is a well known publication throughout the pharmaceutical industry and is operating the interesting and helpful website pharmtech.com. Now we have the pleasure to support this website as well. Thomas Peither is writing a regular column about GMPs from the European view.

The first article is about the FDA Process Validation Guideline from the European view.

Click here for the article: The New FDA Process Validation Guideline