Register now for the free GMP newsletter LOGFILE
and don't miss any news.
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?
9 min. reading time | by Harald Flechl
7 min. reading time | by Simone Ferrante
Every upcoming change must be checked for GxP-relevance by the responsible person for GDP.
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.
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.
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.
9 min. reading time | by Petra Berlemann and Thomas Peither
What is it? How do you create such documents? Is it all the same? Or is it something completely different?
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.
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.
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.
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.
11 min. reading time | by Cornelia Wawretschek, Jens Hrach, PhD
6 min. reading time | by Simone Ferrante
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.
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.
6 min. reading time | by Christine Oechslein, PhD
The quality of a medicinal product cannot be left to chance, but must be the result of carefully planned actions. The sequence "planning, acting, evaluating, improving" is referred to as "management".
9 min. reading time | by Frank Studt and Thomas Peither
9 Min. Lesezeit | Auszug aus dem Interview mit Frank Studt, Managing Director gempex GmbH, und Thomas Peither beim GMP:talk auf den LOUNGES 2022
8 min. reading time | by Thomas Peither
The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.
10 min. reading time | by Sabine Paris, PhD
The new Annex 21: Importation of medicinal products to the EU GMP Guide has been published on February 21, 2022 and will enter into force on August 21, 2022. The 6-page annex summarises the GMP requirements for Manufacturer/Importer Authorisation (MIA) holders to import medicinal products (human, investigational and veterinary) from outside the EU/EEA (we reported).