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Pharma 4.0, Industrial IoT – ISPE GAMP 2018 in Warschau

22. März 2018 | 0 Kommentare

Pharma 4.0, Data Integrity, Internet of Things and role of ICH in “Holistic Control Strategy”: These were the main topics of the GAMP conference titled “Automated systems”. Organized by the ISPE Polish Affiliate in Warsaw from March 14th-15th, the conference was hosted by Gerard Halski (Chairman of GAMP Poland) and Rafal Buczek (member of ISPE Poland management board)
As was to be expected with those topics and expert speakers from the pharmaceutical industry on the agenda,…

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Kalbio Global Medika – Trailblazing a new chapter in Biologics

20. November 2017 | 0 Kommentare

by Ming Chua, Partner HGP Asia
 
A big congratulations to the Class of 2016-2017 of Kalbio Global Medika’s Biomanufacturing Training Program that graduated on 12 Oct 2017!
From Oct 2016 to 2017, this class of 31 young men and women from all walks of life came together to learn about upstream,…

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Internet of Things and Pharmaceutical Industry

13. Juli 2017 | 0 Kommentare

by Ming Chua, Partner HGP Asia

The Internet of Things is here and it is going to change every aspect of our lives and we in the Pharmaceutical Industry have to be ready for a culture shock!
In the past 6 months, I’ve been spending time this year learning about and being exposed to the Internet of Things,…

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Does GMP Need to be Upgraded?

7. Mai 2017 | 0 Kommentare

Deadly Hyper-Pathogens From Pharmaceutical Plants – Does GMP Need to be Upgraded?
As reported by several media all over the world last week, hyper-pathogens that are resistent against multiple antibiotics have been found in waste water in the area of Hyderabad in India. According to a report in The Times of India from April 30th,…

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MES – Challenges of Implementing a Business Transformational Tool

26. September 2016 | 0 Kommentare

Over the past 3 years, I’ve had the privilege of traveling and meeting with customers all over Asia to promote our services in Manufacturing Execution Systems (MES) implementation.
These customers were all large successful manufacturers in Singapore, China, Taiwan and India, and all were already implementing MES or were very interested in having one.…

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MES Systems in Pharmaceutical Production – 5 Steps to a Successful Migration

12. September 2016 | 0 Kommentare

So you’ve been using your MES (Manufacturing Execution System) for a good few years now – it’s hard to remember a time without it.  The benefits have been realised and using MES has become an essential part of your manufacturing and operational processes.  However as technology evolves and times change,…

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Cloud Computing in Pharma – the next frontier?

16. August 2016 | 0 Kommentare


In the last 15 years, “Cloud Computing” has revolutionized many areas of our lives and many businesses around us.  From how we store our photos and music, to how we pay our bills and buy our groceries, without The Cloud the ease and convenience of doing these tasks would not be possible.…

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How to take the right decision: Upgrade or replace the current MES?

9. Mai 2016 | 0 Kommentare

 
In the first part of our blog on Pharma MES migration „5 good reasons to upgrade or replace your Pharma MES“ we discussed the signs that show you that you need to do something about your MES system.

The second part is about decision-making: When is the right moment to change?

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FDA Leitlinie zur Datenintegrität – 18 Fragen & Antworten

17. April 2016 | 0 Kommentare

Am 14. April 2016 hat die amerikanische Bundesbehörde FDA den Entwurf zur Datenintegrität veröffentlicht: Leitlinie für die Industrie zu Datenintegrität und Einhaltung der aktuellen Guten Herstellungspraxis. Es handelt sich um ein Frage- & Antwortendokument, das 18 Fragen bezüglich der Datenintegrität behandelt und die Meinung der FDA zur Rolle der Datenintegrität in der aktuellen Guten Herstellungspraxis (cGMP) für Medikamente darlegt,…

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EU-GMP Annex 16: Die 6 wichtigsten Punkte

14. April 2016 | 0 Kommentare

The European Commission has prepared the revision of Annex 16 to the EU Guidelines for Good Manufacturing Practice for Medicinal Products „Certification by a Qualified Person and Batch Release“.
Coming into operation as of 15th April 2016, every GMP expert should be informed on the main topics that are different.…

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