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GMP LOGFILE: Lead Article

Agency Expectations on PDE Reports


8 min. reading time | by Sabine Paris, PhD


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. Instead of the previously used criteria, such as 10 ppm or 1/1000 of the therapeutic dose of the foregoing product, now the sole admissible criterion is a toxicological risk assessment based on PDE values.

GMP Risk Analysis in Qualification


18 minutes 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 minutes reading time | by Markus Veit, PhD


Excerpt form the GMP Focus Data Integrity in the EU

Rouging When Stainless Steel Corrodes


12 minutes reading time | by Herbert Bendlin, PhD


Excerpt form the GMP Compliance Adviser, Chapter 5.E Operation and maintenance of water systems

The GMP Regulations Report 2020


11 min. reading time


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 minutes 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. Wall and ceiling systems are flexible when it comes to planning and installation; subsequent modifications can be made quickly and easily.

EMA Guideline on the Quality of Water for Pharmaceutical Use


12 minutes reading time | by Tim Sandle, PhD


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. Concerns with endotoxin risks in relation to reverse osmosis are central to a new European Medicines Agency guidance paper relating to pharmaceutical water production. This article considers the key messages within the guidance and the important learning points in relation to contamination control.

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


10 minutes reading time | by Doris Borchert, PhD and Christian Gausepohl, PhD


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. Everyone has a bad day, is distracted or unfocused, forgets or mixes things up and makes mistakes, even though they "actually" know how to do it correctly.

2 Approaches for Implementing ICH Q3D


10 minutes reading time | by Paulino Alonso, PhD


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 minutes 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.

In this feature you now have the opportunity to view the most clicked questions in 2020. Could you answer them yourself? If not, you are not alone. Subscribers to the GMP Compliance Adviser just follow the additional link and get even more in-depth knowledge from the GMP Compliance Adviser.

26th PTS GMP Conference – Current Topics Presented Virtually


12 minutes reading time | by Doris Borchert, PhD


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. A successful premiere, according to the unanimous feedback of the participants. The conference took place live - and that is exactly what made it very lively and authentic.

Containment in Perfection: The Isolator Technology


10 minutes 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. Containment has a dual significance for the protection of operator health and protection of product. The safest containment is achieved with isolator technology.

Digitalised Crisis Response for Pharmaceutical Production


9 minutes 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. At the same time, new regulations and guidelines for quality assurance of production processes, environments and plant inventories are constantly being added.

Online packaging line controls


6 minutes reading time | by Vera Werner


Excerpt from the GMP Compliance AdviserChapter 13.B.6.2

Brief spots on autumn conferences


5 minutes 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 minutes reading time | by Rainer Gnibl, PhD


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

Insufficient cleaning validation


5 minutes reading time | by Lea Joos


Shortened excerpt from Chapter 21.C.2.5 of the GMP Compliance Adviser

Can the author of a GMP document also act as its reviewer?


3 minutes reading time


Is there a normative source for the fact that the reviewer of a document cannot be the same person who prepared it?

Criticality classifications of deviations


5 minutes reading time | by Felix Tobias Kern, PhD and Liwa Schneider


The correct and consistent classification of deviations into the categories Minor, Major and Critical is a constant challenge for pharmaceutical manufacturers. A systematic specification is a prerequisite for the elimination of subjective components of the classifying QA function and the QPs. This specification also prevents inhomogeneities between the individual decision-makers of the QA and between the individual QPs.

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