Production hygiene or: you can't see problem areas
The pharmaceutical industry sets high standards for production hygiene. The difficult thing about meeting these standards? The problem areas are often invisible. In this episode, find out where the most common sources of contamination are, what crucial role cleaning plays and where disinfection is essential. Immerse yourself in the topic with Thomas Peither and get practical tips [...]
Production hygiene or: you can't see problem areas
The pharmaceutical industry sets high standards for production hygiene. The difficult thing about meeting these standards? The problem areas are often invisible. In this episode, find out where the most common sources of contamination are, what crucial role cleaning plays and where disinfection is essential. Immerse yourself in the topic with Thomas Peither and get practical tips [...]
Production hygiene or: you can't see problem areas
The pharmaceutical industry sets high standards for production hygiene. The difficult thing about meeting these standards? The problem areas are often invisible. In this episode, find out where the most common sources of contamination are, what crucial role cleaning plays and where disinfection is essential. Immerse yourself in the topic with Thomas Peither and get practical tips [...]
AI meets GMP: assured answers with ChatGMP
Experience how artificial intelligence is revolutionizing the world of GMP information: In this presentation, you will get a compact overview of AI, Large Language Models (LLMs) and how they work. We will show you the challenges we faced as a specialist publisher when developing ChatGMP, the new AI-supported search function of the GMP-BERATER, and how we overcame them to [...]
AI meets GMP: assured answers with ChatGMP
Experience how artificial intelligence is revolutionizing the world of GMP information: In this presentation, you will get a compact overview of AI, Large Language Models (LLMs) and how they work. We will show you the challenges we faced as a specialist publisher when developing ChatGMP, the new AI-supported search function of the GMP-BERATER, and how we overcame them to [...]
AI meets GMP: assured answers with ChatGMP
Experience how artificial intelligence is revolutionizing the world of GMP information: In this presentation, you will get a compact overview of AI, Large Language Models (LLMs) and how they work. We will show you the challenges we faced as a specialist publisher when developing ChatGMP, the new AI-supported search function of the GMP-BERATER, and how we overcame them to [...]
Regulatory review 2024
What was going on in the world of GMP regulations in 2024? A look at the highlights of the year shows that it was a year full of exciting developments. The most important topics that came to the table in 2024 range from new regulations in the German Medicinal Products Act (AMG) and the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) to clarifications on Annex 1 and [...]
Cleaning validation & sustainability: do they go together?
The cleaning of production facilities makes an important contribution to drug safety: every facility must be demonstrably clean before production begins so that no residues from the preliminary product can enter the next product. Proof of the reproducible effectiveness of a cleaning process is provided by means of cleaning validation, whereby toxicologically based limit values must be adhered to. In order to be able to "rely on [...]
2.5 years of Annex 1 - what's next?
Richard Denk knows Annex 1 to the EU GMP guidelines like the back of his hand: not only was he part of the industry comment team for the second draft of the document, he also held training courses on the implementation of Annex 1 around the world following its publication. The training courses and workshops took place in Europe, USA, Brazil, South Africa, Egypt, India, Singapore, Japan, Australia and New Zealand [...].
First inspection experiences with Annex 1
Two and a half years after Annex 1 came into force, we would like to ask Xenia Dimont, GMP inspector for the government of Upper Bavaria, about her experiences with inspections of sterile manufacturers that have been carried out since then. The demand for a documented contamination control strategy (CCS) has caused a lot of commotion. What do these documents look like in practice and do they meet the authority's requirements? The [...]