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Doris Borchert
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Doris Borchert

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Published articles

Microbiological monitoring in non-sterile areas

Microbiological monitoring in non-sterile areas

At our GMP Conference, the “GMP-BERATER Tage“, in October 2019 we presented a GMP dialogue on "Microbiological Monitoring in non-sterile areas". Questions on the topic were asked by participants and answered by GMP inspector Franz Schönfeld, PhD and microbiologist Frank Mertens, PhD in a lively discussion.

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Questions about manufacturing technology

Questions about manufacturing technology

At our GMP conference, the GMP-BERATER Tage in October 2019 the GMP-DIALOGUE on the topic "Technology for the manufacture of medicinal products" took place. Questions on the topic were asked by participants and answered by GMP inspector Rainer Gnibl, PhD and technology-expert Ruven Brandes in a lively discussion.

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The power of the comma Or: What do print data have to do with drug safety?

The power of the comma Or: What do print data have to do with drug safety?

Would you have known? Around 90% of all product recalls by pharmaceutical companies are due to errors in printed packaging materials. It is not the quality of the drug per se that calls patient safety into question, but incorrect or faulty information on the packaging.

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Batch Designation: Handwritten or Electronic?

Batch Designation: Handwritten or Electronic?

In our company, every step of the production process is documented on the batch processing record, which is printed out on paper beforehand. Prior to this, all batches used were entered in the record by hand. This often resulted in an unclear spelling.

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Ask our Experts GMP-compliant documentation: Handling of glued-in printouts

Ask our Experts GMP-compliant documentation: Handling of glued-in printouts

Printouts must be labelled properly to ensure they can be clearly assigned. Attached printouts must be marked by an employee in such a way that their initials are half on the printout and half on the paper that the printout is attached to.

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26th PTS GMP Conference – Current Topics Presented Virtually

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.

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Update on Annex 1 of the EU GMP Guide

Update on Annex 1 of the EU GMP Guide

The 27th PTS GMP Conference took place face-to-face and in parallel digitally from 30.11. to 01.12.2021 in Mainz, Germany. The hybrid event was broadcast live from the Atrium Hotel in Mainz, where most of the speakers were present in person. The presentation by Rico Schulze, Saxon State Ministry for Social Affairs and Social Cohesion, on the revision status and publication of Annex 1 to the EU GMP Guideline was particularly eagerly awaited.
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How are Quality Culture and a Symphony Orchestra Similar?

How are Quality Culture and a Symphony Orchestra Similar?

What do you associate with the word “culture”? 
It’s likely to be literature, fine art, or music, but not necessarily GMP. Yet, the term culture has found its place in our professional world in recent years, especially when it comes to quality. Today's editorial by Doris Borchert, PhD, highlights the striking connections between quality culture and a symphony orchestra.

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Supply Shortages – is a Solution in Sight?

Supply Shortages – is a Solution in Sight?

Has it ever happened to you that ‘your’ medicine was not available in the pharmacy? It becomes problematic when the re-availability is not foreseeable, the medicine is urgently needed and no alternatives exist. The topic of ‘supply shortages’ is in the public eye and was also discussed at the 30th GMP Conference, which took place in Cologne, Germany, from 6 to 7 November 2024. Doris Borchert, PhD, attended the conference on behalf of GMP-Verlag. Today she reports on a panel discussion on the topic of supply shortages.

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