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7 min. reading time | by Birte Scharf, PhD
Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.
10 min. reading time | by Thomas Peither
When I worked on the first GMP projects as a consultant in 1994, the internet was still in its infancy. Getting an official copy of 21 CFR 210/211 was more than a hassle. You had to send a written request to the USA and after weeks, a barely legible copy would arrive by post.
6 min. reading time | by Thomas Peither
Ensuring a clean production environment – sounds simple enough.However, in the pharmaceutical context, cleanliness and contamination are clearly defined, delineated and, of course, regulated, particularly in the manufacture of active ingredients and medicinal products.
5 min. reading time | by Sabine Paris
The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024. All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph.
7 min. reading time | by Thomas Peither
Cloud computing is not a new technology, but a new way of providing resources for data processing.
5 min. reading time | by Thomas Peither
The life cycle approach to cleaning validation simply means that control of cleaning effectiveness must be maintained on an ongoing basis.
5 min. reading time | by GMP-Verlag Peither AG
Every week we publish interesting questions and answers about GMP in our column GMP Question of the Week. Today we have compiled the most clicked questions of this year (as of November 2023).
Browse the Top 15 and refresh your knowledge!
Detailed information on each topic can be found in the GMP Compliance Adviser, the world's largest reference work on quality management in the pharmaceutical industry.
7 min. reading time | by Thomas Peither
The stability of a medicinal product or an active substance is defined as the maintenance of certain quality characteristics (specification) over a fixed period of time under defined conditions.
‘Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.‘ This is explicitly stated in the EU GMP Directive 2017/1572.
5 min. reading time | by Thomas Peither
When we take a drug, we first and foremost want it to work – to cure an illness or at least alleviate its symptoms.
7 min. reading time | by Thomas Peither
Subjectivity in QRM should be addressed in every organisation. I had the opportunity to attend a very stimulating presentation by Alex Viehmann, Division Director at OPQ, CDER, U.S. FDA, who shared insights into the new ICH Q9 Guideline on Quality Risk Management (QRM) at the PDA/FDA Joint Regulatory Conference 2023, 18-20 September in Washington.
13 min. reading time | by 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.
The monitoring of critical parameters is largely automated and is part of the plant control system. In the event of a critical system alarm (e.g. TOC outside of tolerance limits), the control system also performs the system shutdown or the transition to a safe operation mode.
4 min. reading time | by Harald Flechl
According to the new Annex 1, a Contamination Control Strategy (CCS) must be implemented for the entire cleanroom and controlled environment system of the facility.
3 min. reading time | GMP-Verlag
Gastrointestinal medicines, headache tablets and perhaps a gel to soothe insect bites? It's no big hassle to pack these and yet they give you a reassuring feeling of security.
10 min. reading time | by Cornelia Wawretschek and Jens Hrach, PhD
One of the basic principles of a cleaning validation is the setting of limits for possible cross-contaminants in the subsequent product.
8 min. reading time | by Thomas Peither
Adequate size and lighting of all areas where medicinal products, starting materials and packaging materials are stored is essential for the proper performance of operations.
5 min. reading time | by Dennis Sandkühler, PhD
Fundamentally, the use of computerised systems in GxP environments requires a consideration of regulatory requirements.
8 min. reading time | by Thomas Peither
The following standards can be used as a basis for cleanroom monitoring plans:
5 min. reading time | by Christoph Brewi and Florian Sieder, PhD
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).