Equipment Qualification

Legal Requirements: Equipment Qualification

With this issue we start  a series of four articles about GMP compliant qualification of equipment in the pharmaceutical and biopharmaceutical industry.

This article is an excerpt of the GMP MANUAL. This way you get a preview on the power of the GMP MANUAL for your daily business.

Qualification - official requirements

10 000 professionals are using the GMP MANUAL

Did you know that our GMP knowledge base is used by more than 10 000 experts around the globe? And the number is rapidly rising!

It provides a solid basis on GMP regulations and interpretations, with focus on the practical approach of performing Good Manufacturing Practice in the daily business. Probably we should say:  Best Manufacturing Practice! This is why the GMP MANUAL is also called "The Authority"

More information...

Latest GMP News

Bayesian Statistical Methods

Focus on GMP Training

Learn form FDA Warning Letters

Recall of USP 33-NF 28

EMA: Roadmap to 2015

EMA FAQ on GMP Topics

You find daily news on our website in the news area. Bookmark the website or use the RSS feed system.

NEW! You can now comment our news.

GMP-Survey: Qualification of facilities and equipment

Please participate in the brief survey below about qualification of facilities and equipment (2 minutes max!).

GMP Survey Equipment Qualification

The results of the last survey about audits is also interesting in regards to qualification. Equipment and software suppliers seem to be rarely audited. Read more in the results.

SurveyResults-Audits.pdf

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

PDA Workshop on Silicon oil

Silicon oil is an important processing aid in the pharmaceutical and biopharmaceutical industry. It is used in elastomeric components and for glass containers.

The workshop will give an overview on all relevant aspects for the use of silicon, an update of the latest technologies and describes current best practice with case studies.

Workshop program "Silicon oil and its Application for Parenteral Products"