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GMP LOGFILE: Lead Article

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)


7 min. reading time | by Stephanie Blum


With this e-learning course you can get familiar with the topic of Good Distribution Practice (GDP)!

Requirements for Balances Used in Pharmaceutical Production


10 min. reading time | by Christian Gausepohl


When selecting balances, technical aspects such as resolution, precision and weighing range must be taken into account, as must special design features.

Design Qualification for Premises and Air Handling Units


7 min. reading time | by Harald Flechl


The design qualification process may vary depending on the project and the client's requirements and may be carried out in two or three design phases.

Contract Manufacturing: Technology Transfer Phases


10 min. reading time | by Chistian Gausepohl


The transfer of a product to a contract manufacturer can be divided into different phases.

Survey of qualified persons on remote certification


15 min. reading time | by Ulrich Kissel and David Cockburn


Social distancing posed an interesting question for the Qualified Person (QP) in the early days of the COVID-19 pandemic:

Importance of Supplier Qualification Status


7 min. reading time | by Christian Gausepohl


Most companies have established different categories (qualification status) for the suppliers of starting materials and packaging materials they use.

Innovations in Pharmaceutical Manufacturing


8 min. reading time | by Thomas Peither


Were you able to follow the PDA Annual Meeting of the Parenteral Drug Association this year? Or were you like many others who spent the whole day with web meetings and have no time or mood for more online conferences?

European Safety Referral: Short and Crisp


4 min. reading time | by Michael Hiob and Sabine Paris,PhD


A referral is a procedure used to resolve concerns over the safety, efficacy or quality of a medicinal product (or a class of medicines). In a referral, the EMA is requested to conduct a scientific assessment of the products in question on behalf of the European Union (EU).

The GMP:Blog is online!


The time has come, the curtain goes up! Now your brand-new online journal is launched.
Let the newly designed GMP:Blog support you in the work with GMP.

Specifications for packaging materials


5 min. reading time | by Roland Kleissendorf


A correctly formulated packaging material specification provides a comprehensive description of the packaging material and serves as a guideline for the respective packaging materials supplier.

Agency Expectations on PDE Reports


8 min. reading time | by Sabine Paris


In 2015, with the revision of Chapters 3 and 5 and Annex 15 of the EU GMP Guide and with the publication of the EMA PDE Guideline a paradigm shift took place in establishing limit values for the validation of cleaning processes.

GMP Risk Analysis in Qualification


18 min. reading time


Today’s feature focuses on GMP risk analysis. It is an excerpt from the E-Learning GMP:READY – GMP for Engineers. GMP:READY provides knowledge for the planning, qualification and maintenance of the pharmaceutical equipment and facilities.

Data Integrity in the Quality Control Laboratory


5 min. reading time | by Markus Veit



This chapter deals with the practical aspects of implementing the European requirements for data integrity.

Insufficient traceability of the batch documentation


12 min. reading time | by Dr. Sabine Paris


The deficiency

Time specifications for the start of production (preparation from 8:30) and for the end of production (15:30) were entered in the batch documentation.

Rouging When Stainless Steel Corrodes


12 min. reading time | by Herbert Bendlin


What is rouging?

The GMP Regulations Report 2020


11 min. reading time | by Sabine Paris


For all of us, the year 2020 turned out quite differently than we had ever imagined. People everywhere are struggling with new challenges. The GMP world was not spared, either. To name just a few: inspections were carried out remotely to a large extent and many regulations remained in draft form for the time being.

3 Systems for Cleanroom Walls


8 min. reading time | by Harald Flechl


Over the past several years, wall and ceiling systems have become the established state of the art in finishing technology. The numerous manufacturers of such systems also offer solutions that are suitable for fire zones and large, high rooms – such as warehouse storage rooms.

EMA Guideline on the Quality of Water for Pharmaceutical Use


12 min. reading time | by Tim Sandle


Controlling water quality in pharmaceutical facilities requires an assessment of chemical and microbial risks. Of foremost concern is water-for-injections (WFI). This grade of water can be prepared using either reverse osmosis or by distillation.

Insight at Second Glance - The Human Error and its Root Causes


10 min. reading time | by Doris Borchert and Christian Gausepohl


To err is human - and is only too willingly used as the most probable cause for deviations of all kinds. It is also temptingly easy to look for the cause of error in individual (mis)behaviour.

2 Approaches for Implementing ICH Q3D


10 min. reading time | by Paulino Alonso


ICH Q3D 'Guideline for Elemental Impurities' applies to finished drug products. It provides the basis for an adequate control of elemental impurities (generally referred as 'heavy metals' or 'metallic impurities'). The publication of this guideline has brought several consequences:

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