This year-end edition of our newsletter marks 2 years since we started this endeavour. We hope that you find it interesting and that you've been able to attend some of our events, whether social or educational.
To echo an oft-cited industry mantra, we aim for continuous improvement and to serve you better. Our recently concluded annual meeting met with good reviews and we thank everyone who participated.
Now we're excited for our first joint ISPE US-Asia Pacific Conference on GAMP Data Integrity from next month. We're delighted to have US FDA speaking, alongside experts and case studies including Eli Lilly, GSK and Merck Biopharma. Please come and encourage your colleagues here and in the region to join us at this valuable gathering.
We look forward to seeing you soon.
As we enter the holiday season, we wish all a Happy Deepavali, Merry Christmas and Blessed New Year!
Best Regards,
your ISPE Singapore Affiliate
|
Michael Rutherford
GAMP Global Chair, GAMP Data Integrity SIG Sponsor, ISPE 2016 Joseph X. Phillips Professional Achievement Award, ISPE 2014 Member of the Year, 2016 and 2017 ISPE Annual Meeting Education Program Chair, ISPE 2017-2018 International Board of Directors
Over the last 5-7 years, it is no surprise that data integrity has become one of the hottest regulatory and compliance topics affecting not only the pharmaceutical industry, but the scientific community. You cannot read a regulatory inspection report or warning/ untitled letter today without finding at least one, and usually more, data integrity related observations. The retraction of scientific articles in reputable scientific and medical journals has also increased due to concerns about the integrity of the data and results, raising concerns about basic research and the data associated with drug products. Data integrity is a global regulatory and compliance expectation, and actually not a new expectation. Data integrity regulations and requirements have truly existed since the 1970's and 21 CFR Part 11 actually celebrated its 20th anniversary this year.
Regulatory agencies, as well as industry, rely on accurate information to ensure drug quality. If the information associated with a drug product is not accurate or reliable, there is no way a company can ensure the safety and efficacy of their products for the patient. And global regulatory agencies are becoming more aligned around these expectations. Non-compliance has resulted in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, Application Integrity Policy Invocations/ legal action, and most concerning, a potential for patient harm and an impact to the pharmaceutical supply chain. It is as much a compliance issue as it is a financial issue, as seen by the impact of these regulatory actions on companies bottom lines.
It is important to note that data integrity really comes down to two key elements: data governance and data life cycle management.
When we talk about management systems and governance, we are talking people, process, and technology and the associated behavioral, procedural, and technical controls.
|
How does UV light compare against other traditional technologies to remove chlorine?
by Tim McDougle, Sales & Marketing Director, Hanovia Ltd
For more than 100 years, chlorine has been utilized as the most common disinfectant for water processes. It is easy to produce, inexpensive and aggressively disinfects most micro-organisms. Industrial users commonly dose chlorine within their manufacturing processes, either to secure the water supply or as a CIP chemical for process equipment.
For critical applications, such as the production of pharmaceuticals, cosmetics, microelectronics and power generation, where inorganic quality needs to be of the highest standard, RO is combined with Electro-deionization (EDI) as common practice to guarantee sub-ppm levels of salts as measured by the water's resistivity. While RO and EDI are, stable technologies requiring minimal operator, maintenance compared to traditional cation / anion ion-exchange beds, they do need protection from oxidizing species which will affect both performance and lifespan. For this reason, the removal of free chlorine prior to RO and EDI is very important.
There have been two traditional methods for eliminating chlorine prior to RO and EDI: Activated Carbon Filtration (ACF) and Sodium Meta-Bisulphite dosing (SMB). Both methods are well proven but, while offering secure chlorine removal, exhibit certain properties and operating limitations which can impact a water treatment process. These can lead to increased bio-burden and higher operating costs (chemicals, water, operator labor) which are not ideal, especially in hygienic processes such as the manufacture of pharmaceuticals and beverages.
|
Did you read...
FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence.
View Article
The plan was developed by EMA Task Force that was established immediately after the UK referendum.
View Article
How much do you think the pioneering cancer drug will cost?
View Article
Make way for a brand new class of medicine from Alnylam Pharmacueticals!
View Article
Using Trending As A Tool For Risk-Based Thinking
View Article
|
|
|
|
|
 |
|
IChemE Singapore Awards
19 Oct 2017
ISPE Singapore is pleased to be supporting this event in judging the awards.
3 Nov 2017 | 2.30 - 5.00pm
Matrix Building, Biopolis, Singapore
Hear from Dr Oh Ching Mien and Dr Chew Wee on
Regulatory Aspects of QbD and PAT - A Dialogue Session
ISPE 2017 Asia Pacific GAMP Data Integrity Conference
13/14 Nov 2017 | 8.30am-5.00pm
NTU Alumni Club @ OneNorth
ISPE Soccer Tournament 2017
24 Nov 2017 | 7-9pm
GOLAZO Futsal Singapore
Join us for this annual challenge at the newly renovated Golazo Futsal Singapore.
Sign up with a Team of 8!
Thirsty Thursday with ISPE!
4 Jan 2017 | 6.30 - 8.30pm
Unwind, meet old and make new friends conveniently in Jurong East! Finger food & first round on the house, thereafter 1 for 1 Happy Hour. Bring a friend from or if you're full time staff from bio/pharma manufacturing facility, enjoy bonus drinks!
ISPE Singapore AGM & Dinner
Phar-East 2018
1-2 March 2018
Suntec Convention & Exhibition Centre
Asia's pharma & biotech festival, showcasing the very best in Asian pharma excellence. It's where big pharma and biotech, regulators and payers, solution providers and technology leaders all come together to build new relationships, cement existing partnerships and chart the path forward in Asia's life sciences industry.
ISPE Singapore Conference &
Exhibition
29-31 August 2018
Mark your calendars for our annual event, packed with learning, case study experience and informative exhibition. Limited exhibit spaces & sponsorship available, contact
yvonne.leong@ibcasia.com.sg
for details
Contact us if you'd like to include your
event here. (Postings are vetted according to ISPE guidelines on commercial content and subject to approval by the committee.)
|
|
Cleaning Validation Workshop
16/17 Oct 2017,
Bangkok, Thailand
18/19 Oct 2017,
Jakarta, Indonesia
ISPE Philippines Seminar on PIC/S updates and Project Management
14/15 Nov 2017, Crowne Plaza Hotel, Quezon City
|
Join our exclusive
PAT CoP Email-List and find out about all upcoming PAT related activities.
We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?
|
|
|
|
|
|
Join us for this this must-attend event, featuring keynote addresses from global industry leaders:
Karen Takahashi
Senior Policy Advisor, US FDA/CDER/OPQ
Current Regulatory Trends and FDA's Guidance for Industry Data Integrity and Compliance with cGMP
Ian Thrussell
former WHO GMP and UK MHRA Expert Inspector, Switzerland
Data Integrity: The Challenges to Meeting Regulatory Requirements
Michael Rutherford
Consultant - Laboratory and Quality Systems, Medicines Development Unit (MDU) - Business Systems Support, Eli Lilly and Company, ISPE GAMP® Global Chair and GAMP® Data Integrity SIG Sponsor, USA
Addressing Data Integrity Across Global Organisations: Regulations, Systems, and People
Here is a sampling of what else you can expect:
-
Gain insight into the latest requirements and practices to enable robust data management and data integrity across the product life cycle
- Hear directly from US FDA on industry guidance and cGMP compliance
- Gather case study experience from global manufacturers, Eli Lilly and Company, Merck Group, GSK, and AbbVie
- Learn from practical workshop sessions, Q&A, and interactive panel discussions
All attendees may save
20% off
the latest
GAMP Records & Data Integrity Guide!
|
|
|
ISPE Singapore Conference and Exhibition 2017
Over 800 attendees from Singapore and beyond came to hear from MHRA and regional regulators, manufacturers and experts. Thanks to all who participated, including our speakers, sponsors and exhibitors.
ISPE Singapore Student Poster Competition 2017
Congratulations to Himanshu Kathuria, for winning this year's ISPE Student Poster Competition and a full-expense paid trip to the ISPE Annual Meeting in San Diego, USA! The ISPE Team wishes him All The Best and a good trip to the USA this month!
ISPE Singapore Go-Kart Challenge
Held on the Friday just before the F1 Grand Prix, our own intrepid racers took to the full track at KF1 Karting. Congratulations to our winner David Monaghan from PM Group, followed by Hugh McKee (PM Group) in 2nd and Patrick Bernanose (M+W Group) in 3rd place.
8 Sept 2017 - Site Tour to Novartis
13 Sept 2017 - Site Tour to Abbott
15 Sept 2017 - Site Tour to Merck
Thank you to our kind hosts for giving us a peek into your facilities. It has been a great experience which we hope to repeat next year.
Thirsty Thursday
5 Oct 2017
Our 2nd quarterly social gathering had over 30 friends and colleagues. Mark your calendar for next year's first event on 4 Jan!
|
|
Your feedback and suggestions are most welcome as we strive to provide you with membership and industry news updates.
|
|
Contact Us
ISPE Singapore Affiliate
Ph +65 6826 1105
|
|
|
|
