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GMP LOGFILE: Lead Article

Regulatory Requirements for Computerised Systems


5 min. reading time | by Dennis Sandkühler, PhD


Fundamentally, the use of computerised systems in GxP environments requires a consideration of regulatory requirements.

Air Handling Systems: GMP Compliant Monitoring and Energy-Saving Operation


8 min. reading time | by Thomas Peither


Standards and Data Types

The following standards can be used as a basis for cleanroom monitoring plans:

New in Annex 1: the Contamination Control Strategy (CCS)


5 min. reading time | by Christoph Brewi and Florian Sieder, PhD

What is meant by CCS?

The current Annex 1 (version of 22/08/2022) of the EU GMP Guide marks a paradigm shift in the rules and regulations of Good Manufacturing Practice (GMP).

Reference Standards in the Pharmaceutical Laboratory: Procurement and Characterisation


5 min. reading time | by Stephanie Blum

Reference standards

Pharmacopoeial standards are obtained by the chemicals officer from the issuing body and do not require further characterisation before use.

Biotechnological Medicinal Products: Global Trends and Perspectives


5 min. reading time | by Sabine Paris

The Swiss Biotech Day 2023 took place on 24 and 25 April in Basel. The conference is one of the industry's most important meeting places for developers and manufacturers of biopharmaceuticals and is growing in popularity every year.

GMP Compliant Plant Qualification: Software Quality Plan


10 min. reading time | by Petra Berlemann


A software quality plan – what is it and how do you create such a document?

greenGMP Supports the Sustainability Goals in the Company


7 min. reading time | by Thomas Peither

You know the sustainability goals in your company, such as achieving CO2 neutrality by 2030 or 2050. But what does that have to do with GMP?

Change Control at the Wholesaler or Logistics Provider: Assessment of GxP Relevance


7 min. reading time | by Simone Ferrante


Assessment of GxP relevance

Every upcoming change must be checked for GxP-relevance by the responsible person for GDP.

Qualification of Water Supply Systems – Introduction


4 min. reading time | by Fritz Röder

Pharmaceutical water systems are used for a number of different applications by pharmaceutical manufacturers. These include, for example, the cleaning of various pieces of equipment, the generation of pure steam and the use of water as an ingredient for solid, semi-solid and liquid medicinal products.

Document and Evaluate GMP Audit Information and Findings


7 min reading time | by Stephanie Blum, PhD

In the course of an audit, the auditors collect the information necessary to achieve the audit objectives on a sample basis, e.g. by inspecting premises, observing operations, interviewing personnel and examining documents and records. Interviews may be conducted at any time during the audit, including during the walkthrough and review of documentation.

Deviations Happen because People Make Mistakes...


8 min. reading time | by Thomas Peither

In this feature we take look at the ‘black sheep’ of pharmaceutical production. As cute and charming as they may be in the animal world, in the world of GMP they can be rather disturbing.

7 Questionnaire Blocks for PLC User Requirements


9 min. reading time | by Petra Berlemann and Thomas Peither


User Requirements, User Requirements Specification (URS), Specification Sheet

What is it? How do you create such documents? Is it all the same? Or is it something completely different?

How to Maintain the Qualification Status of Your Equipment


9 min. reading time | GMP-Verlag


The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned.

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


13 Min. 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.

GMP is not ISO 9001 – Where are the Similarities and Differences?


7 min. reading time | by Thomas Peither


Standards such as those in the DIN EN ISO series are not laws, so ISO standards differ quite fundamentally from legally binding regulations. Good Manufacturing Practice (GMP), on the other hand, is laid down in laws, regulations and guidelines.

Qualification Master Plan: Regulatory Requirements


11 min. reading time | by Thomas Peither


A definition of the term “qualification master plan (QMP)“ is not to be found in the GMP guidelines, only the term “validation master plan (VMP)”, which serves as a parent document.

Basis of Cleaning Validation: Setting of PDE Limits


11 min. reading time | by Cornelia Wawretschek, Jens Hrach, PhD


Cleaning Validation

4 Questions on the Import of Medicinal Products and APIs


6 min. reading time | by Simone Ferrante


GMP or GDP – Which applies for importation?

Although the import of medicinal products is an act related to dis-tribution and logistics, this activity is considered GMP relevant in the EU and is therefore subject to GMP requirements.

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems


8 min. reading time | by Richard Denk

The first draft of version 9 of Annex 1 of the EU GMP Guide on 20 December 2017 attracted a lot of interest globally – firstly because it was the first publication on the topic in almost a decade, and secondly because PIC/S and WHO co-authored the document.

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