Pharma 4.0, Industrial IoT – ISPE GAMP 2018 in Warsaw

Mar 22, 2018 | 0 Comments

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

Nov 20, 2017 | 0 Comments

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

Jul 13, 2017 | 1 Comment

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?

May 7, 2017 | 0 Comments

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

Sep 26, 2016 | 2 Comments

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

Sep 12, 2016 | 0 Comments

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?

Aug 12, 2016 | 3 Comments

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?

May 9, 2016 | 0 Comments

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 draft guidance on Data Integrity – 18 Questions & Answers

Apr 17, 2016 | 2 Comments

On April 14th 2016 U.S. Food and Drug Administration published a draft guidance for comments on Data Integrity: Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry. The draft guidance is a question & answer document, raising 18 questions regarding data integrity and provides FDA’s current thinking about the role of data integrity in current good manufacturing practice (CGMP) for drugs,…

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EU-GMP New Annex 16: The 6 most important points

Apr 14, 2016 | 0 Comments

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 what matters in the new Annex 16.…

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