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GMP LOGFILE: Lead Article

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:

TOP 15 Countdown: "Question of the Week"


10 min. reading time


Every week we publish GMP related questions which you might have asked yourself before. You get short and precise answers, links and working material to the corresponding chapters in the GMP Compliance Adviser.

26th PTS GMP Conference – Current Topics Presented Virtually


12 min. reading time | by Doris Borchert


There is a first time for everything - in this case for the digital format of the GMP Conference, which PTS Training Service organised for the 26th time on 1 December 2020.

Containment in Perfection: The Isolator Technology


10 min. reading time | by Richard Denk


The literal meaning of containment is “holding together” or in its common sense “limiting expansion”. In the active ingredient, pharmaceutical and biopharmaceutical industries it is understood to mean the enclosure of a production process or a dangerous location.

Digitalised Crisis Response for Pharmaceutical Production


9 min. reading time | by Felix Michler


The demands on manufacturers in the pharmaceutical industry are constantly increasing. Global competition and the international production and supply of raw materials and active ingredients increase the complexity of supply chains.

Online packaging line controls


6 min. reading time | by Vera Werner

Brief spots on autumn conferences


5 min. reading time | by Thomas Peither


In September 2020 the series of virtual autumn conferences of PDA and ISPE started. We were present and pick out some excellent sessions with this LOGFILE feature.

Certification of products manufactured outside the EU


6 min. reading time | by Rainer Gnibl


Excerpt from the GMP Compliance Adviser Chapter 14.J and the GMP Series e-book EU-Compliant Batch Release of Medicinal Products

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