We hope you'll enjoy our 2nd edition of the Singapore affiliate's newsletter.
Please send us your feedback and suggestions for improvement. We welcome your news and look forward to meeting you at the various social and educational events lined up for both members and non-members!
Best Wishes,
from your ISPE Singapore Affiliate
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Thailand Committee
(Tony Margetts 4th from left)
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Guest Editorial
Anthony Margetts
ISPE Thai Affiliate Committee Member
The role of ISPE in Thailand
Current Situation
The Asean group of nations have adopted PIC/S as the regulatory standard for the region. This has encouraged some local companies (Regional Leaders) to invest in new facilities.
What does a typical Thai company look like?
A typical Medium Sized Pharmaceutical Production Company in Asean Region produces formulated product and packing. The company distributes its products to hospitals, wholesalers and major retail outlets often through government contracts. Some companies export to other Asean countries.
In this typical facility there are 600 staff, producing 200 products. The products are mainly OSD with 'conventional API' (no potent products), also liquids and creams.
A few companies also have some sterile production, typically LVP IV (saline and dextrose) and SVP typically optical solutions. In our typical facility there are 30 batches per week in multiproduct processing plant, with 'open ' processing, a typical batch is 1 million tablets.
ISPE Thailand
Formed in 2003, the second affiliate in the region, after Singapore. The Thai affiliate has a main objective to help the industry come up to international standards with 4 meetings per year. We have had successful meetings covering:- GEP, URS, Commissioning and Qualification, Water Systems, HVAC,Risk Management and Cross contamination.
Thai FDA
Because ISPE is a non profit organisation, we can invite the Thai FDA. The Thai FDA have recognised the role that we provide; they always attend and we have provided specific training for them.
At the Thai Industrial Pharmacists Association (TIPA) meeting held in Bangkok, the Thai FDA announced the outcome of recent inspections by the PIC/S auditors who accompanied them, of Silom Medical, Unison and Mega Lifescience. The expectation here is that Thai FDA will get the PICS certificate maybe this or early next year. Our ISPE program has helped the Thai FDA to get to this point.
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Carlos Pereira
Head Novartis Singapore Pharmaceutical Manufacturing
ISPE SG: What brought you to Singapore?
CP: Basically two factors: The attractiveness of the Site Head position itself, and also the possibility for me and my family to learn from such a diverse culture as that of Singapore. It is being a very rich experience for all of us, enjoyable every day.
ISPE SG: How does your experience here compare with your previous postings?
CP: Singapore has become a pharmaceutical hub with many companies having manufacturing operations here. This has many positive aspects. For example there is an Biomedical Manufacturing Advisory Committee (BMAC) where most biomedical companies are represented to collaborate in areas like sustainability or improvement of infrastructures. Such a large pharmaceutical presence also presents challenges but they are outweighed by the benefits.
ISPE SG: What prompted your participation in this year's Conference Planning Committee and what highlights are ahead at the 2016 Conference?
CP: I was happy to be given the opportunity to offer my input in shaping the Conference, in contributing with my grain of salt to try make it relevant and interesting. Participating has given me the possibility to get to know subject matter experts and people with a broad network, which is very valuable.
ISPE SG: Anything else that you'd like to share with our readers?
CP: Yes. A lot of time and effort is put in the organization of this event. Topics are carefully selected and so are speakers. It will be a great opportunity for participants to know the latest developments and continue enhancing their professional network. I hope everyone will find it interesting and enjoy it.
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Featured Article
NO DEVIATION AN INTRODUCTION:
No Deviation Pte. Ltd. is a Client Orientated engineering
company, providing technical service to end-users in Singapore, Asia and Europe since our establishment in 2007. Our main areas of operation are within the Bio-Pharmaceutical industry with a focus on Commissioning & Qualification.
Mission Statement
At No Deviation we believe in a practical approach to Commissioning & Qualification while implementing the latest in risk based approach
"Matching client's needs with what is technologically feasible and viable as a business strategy"
With a focus on implementing a solid foundation and structure based on current industry practices along with the integration of client Personnel to provide practical hands-on experience, ND Pte. Ltd. can provide the resources to lead or support your Commissioning and Qualification effort.
Our success is derived from fostering a common goal and defined objectives within the Commissioning and Qualification team and external actors while delivering the guidance and leadership to realize the client's objectives.
UNDERSTAND - OBSERVE - DEFINE - IMPLEMENT
*
the client's drivers to develop appropriate support solution
* and
communicate to develop a sense of empathy
*
client's needs and develop insights
* identified support needs and continually assess the efficiency of the planned actions
How we can support
Whether as part of an Integrated Team, or overall scope management, our team with their strong practical and hands-on background have a proven experience in developing and implementing strategies and organizations to suit the project drivers.
Pierre WINNEPENNINCKX
Managing Director
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FEATURED COURSE: ISPE Certified Training
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Practical Implementation of Process Validation Lifecycle Approach (T46)
11-13 May 2016
Concorde Hotel Singapore
ISPE has been delivering training courses since 1998. Our courses are viewed by manufacturing professionals and regulators worldwide as the go-to resource for expert-knowledge.
Our training courses:
- Provide an in-depth understanding of "how" and "why".
- Use lecture, group exercises, case studies, and ISPE's Guidance documents to provide you with tangible "take-a-ways" for immediate application on the job.
ISPE Singapore is proud to present the only baseline guide training offered in Asia for 2016. This unique opportunity brings a
world renown trainer to your door step,
saving time and and travel costs for your organization.
Upon completion of the training course, attendees will be provided with a certificate from ISPE which demonstrates the attendee has the following skills:
- Develop and execute validation master plans and validation protocols
- Understand and use FDA's current process validation guidelines
- Successfully run conformance lots for process qualification
- Define key validation activities for biopharmaceutical process development and manufacturing
- Apply strategies and fundamental approaches for process validation of upstream and downstream processes for clinical and commercial manufacturing
- Discuss validation documentation requirements
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ISPE Quiz Night 2016
(Sold Out)
15 Apr 2016 | 6.45-9.30pm
Harry's@HarbourFront
Our most popular social event of the year!
Workshop and Hands-On Demonstration on
Glove Testing System
Introduction of new Weight-Hardness-Thickness Tester
21 Apr 2016 | 5-6.30pm
Raffles Marina
Facilitated by Adjuvanz. Registration closes on 18 April.
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Introduction to Statistics for Validation Workshop
10 May 2016 | 2-5pm
Concorde Hotel
Attend this standalone session or combine it with the ISPE PV Training to maximise learning!
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ISPE Training: Practical Implementation of Process Validation Lifecycle Approach (T6)
11-13 May 2016
8.30am-5pm
Concorde Hotel
ISPE Certified Training, co-organized with ISPE ASEAN & Australia
Click here for registration and details |
Hazards 2016
16-18 May 2016 | 9am-5pm
The Ritz-Carlton
IChemE extends special member rates to ISPE members!
OPEX Roadshow 2016
25 May 2016 | 9am-5.15pm
St.Gallen Institute of Management in Asia
Brought to you by the University of St. Gallen.
ISPE members enjoy a special discount of 15%.
A Head Start in the Pharmaceutical and Biotech Industry
27 May 2016 | 6-9.30pm
NUS
Guest Speakers from ISPE, Lend Lease, No Deviation, Novartis and PM Group.
Free for YPs and Students!
ISPE Singapore Conference & Exhibition
24-27 Aug 2016
Suntec Convention
Our annual gathering.
View 2015 event photos
here
ISPE Singapore Student Poster Competition 2016
25 Aug 2016
Suntec Convention
1st prize: all expense paid trip to the ISPE Annual Meeting in Atlanta, GA USA
YP Go-Karting Challenge
2 Sept 2016 | 6.30-9.30pm
Rev up and test your driving skills! Open to all and organized by the Student and Young Professionals.
Registration opening soon!
Effective Pharmaceutical Audits & Self-Inspections
PQMS Auditor/Lead Auditor Course A17638
28 Nov - 2 Dec 2016
Marina Mandarin
View 2015 event photos
here
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.)
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Recruitment:
Young Professional Executive
ISPE Singapore is looking for a young professional to join the team, on a full time basis.
Responsible for supporting the association in communications, social media and organization, the ideal candidate will possess a scientific and/or engineering education and preferably some work experience.
For a job description and to apply, please contact
Kristina
Did you know?
NEA administers incentives to help companies embark on EE-related projects during different stages - design energy efficient new industrial facilities, conduct energy audits to identify potential energy saving measures in existing facilities and retrofit existing industrial systems with energy efficient technologies.
We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?
A S$50 voucher will be given for each one featured in the next issue. Please write in to [email protected]
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ISPE Singapore Student AGM
Congratulations to the new Student Chapter EXCO: Wendy Han (President), Kimberly Siacor (Vice President), Jonathan Tan (Secretary), Liu Chin Mei (Treasurer), Jia Huan Wan (HR), Collin Chong (PR), Ziling Zeng (Info-Comm Tech).
We are looking forward to some great student activities this year!
View photos here
BioPharma Asia Convention 2016
ISPE Singapore participated for the first time at the conference and exhibition. Thanks to our Exco members for welcoming visitors to our stand over the 2 days. They shared information about ISPE Singapore affiliate and recruited some new members at the show!
Pierre Winnepenninckx chaired and moderated a Panel Discussion in the Manufacturing track on 23 March. Thanks to all panelists and ISPE Singapore members who provided a lively and interesting session on:
What's next for Biologics manufacturing in Asia?
- Wee Chew, Research Scientist, Institute of Chemical & Engineering Sciences (ICES)
- Steven Lee, Global Head, Technical Operations, Dr Reddy's Laboratories, India
- Raman Srinivasan, Vice President & Head of Operations, Biocon, Malaysia
- Richard Goodman, Director, Technical Development, Global Manufacturing and Supply, GSK
View photos here
Cleaning Validation: A Life Cycle Approach
Last held in 2014, this year's seminar was packed with 90 attendees and made possible by STERIS. Sponsored by CAI, No Deviation & STERIS.
ISPE Singapore AGM & Dinner 2016
Over 50 members and non-members attended this year's AGM, to elect the new Executive Committee (
EXCO 2016). An evening of networking followed.
Thanks to sponsors 1Supplier, CAI, No Deviation & STERIS for their support.
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Your feedback and suggestions are most welcome as we strive to provide you with membership and industry news updates.
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Contact Us
ISPE Singapore Affiliate
Ph +65 6826 1105
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