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,…
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,…
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,…
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.…
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,…Read more
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.…
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?
On April 14th 2016 U.S. Food and Drug Administration published a draft guidance for comments on Data Integrity: Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry. The draft guidance is a question & answer document, raising 18 questions regarding data integrity and provides FDA’s current thinking about the role of data integrity in current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,…Read more
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.…
A couple of years ago I received an emergency call from one of our clients: “Hey Thomas, I just got a message from IT who told me that they will no longer support our current IT infrastructure for MES!…Read more