Manufacturing Improvement

Manufacturing Improvement by Variation Research

We are always looking for techniques to improve the quality and efficiency of pharmaceutical manufacturing. In our research we found an interesting article that was written in 2004 but is still a very interesting description of helpful methods.

Variations are often the reason for rejections, failures and batch loss. And the increasing global competition asks for methods to identify variations. The following article describes the variation research technique:

Variation Research

Never ever a 483?

We can not promise that you will never get a 483 but we know that the GMP MANUAL includes all the procedures and processes you need to be GMP compliant.

Read 10 valuable reasons why the GMP MANUAL is the leading knowledge source in GMP for the global pharmaceutical industry.

Improvement with Six Sigma

Rolf Staal is an excellent international expert in Six Sigma. He wrote the article about Six Sigma in the recent Update 7 of the GMP MANUAL. The reading sample will touch on the basics of SIx Sigma:

• What it is / what it does / how it works
• The concept
• Six Sigma Expert / the Black Belt
• Six Sigma Organization
• Roles & responsibilities
• Six Sigma approach

You will find the full content in the GMP MANUAL.

Reading Sample Six Sigma

Latest GMP News

Here you find some interesting news we published recently on our website:

The "Problem" is Variability

QbD, PAT, Design Space - Evdokia Korakianiti, EMA Quality Sector, gave a lecture about this issue recently in London.

Example of QRM Implementation

An informal Working Group within PIC/S has developed an example of methodology for the implementation of Quality Risk Management (QRM) in the pharmaceutical industry.

2010 Work Plan for the EMA GMP/ GDP IWG

EMA (EMEA) has published their 2010 Work Plan for the GMP/ GDP Inspectors Working Group on January 12, 2010. Among other themes, there are several GMP and GDP topics concerning the EU GMP Guide identified as "high priority"  in 2010.

Part III of the EU GMP Guide planed

The European Commission's Draft Group Enterprise and Industry launches a public consultation on Part III of the good manufacturing practices laying down guidance to manufacturers in preparing site master files. The European Commission published this draft document on January 12, 2010. The consultation period ends on March 31, 2010.

Find all the GMP MANUAL NEWS on our website

GMP-Survey: Audits

Sometimes it is interesting to know what other companies think about specific topics. Starting with this issue of our newsletter LOGFILE  we will regularly include surveys about GMP topics and aspects. It takes approx. 1-2 minutes to answer the questionnaire.

We will publish the results of the surveys in the next issue of the LOGFILE. We hope that a lot of readers will participate.

Click here to get to the survey about GMP audits.

GMP MANUAL Volume 1 - Manufacturing

The brand new and up-to-date practice book MANUFACTURING is now available.

It supports staff in the pharmaceutical production field by providing internationally accepted GMP guidance. In this book, international GMP experts share their knowledge of GMP implementation according to GMP regulations of the FDA, Europe, ICH, PIC/S and WHO. You’ll learn how noted industry specialists solve the quality challenges in their companies. Improve and fine-tune your procedures accordingly. You will receive answers to quality related questions that affect your daily business.

Chapters: Production, Packaging, Laboratory and Analytical Control, Documentation. This is an excerpt from the comprehensive reference work GMP MANUAL.

620 pages, € 175 / US$ 250

More information: Volume 1 Manufacturing