The festive season and year end is fast approaching.
Soon, it will be time for our AGM and nominations for the new committee. We seek your active involvement to better reflect the industry's learning needs as well as social and networking opportunities. As we plan the programme for 2017, we welcome your feedback and suggestions for events and activities.
This is the 4th and final edition of the newsletter for the year and we hope that you find the updates interesting and useful.
We wish you and your loved ones happy holidays and a healthy new year ahead!
Best Wishes,
from your ISPE Singapore Affiliate
|
Chew Wee
Scientist at Institute of Chemical and Engineering Sciences, A*STAR
Process Analytical Technology (PAT) has been a buzzword since the turn of this century, with its introduction by the U.S. FDA formalized through a guidance paper published in 2004. PAT is intended as a complementary framework for delivering the science-oriented 21st century cGMP that FDA espoused alongside the ideology of quality-by-design (QbD).
Besides the regulatory perspective, PAT is a multi-disciplinary endeavor that includes: process development, process analytical chemistry, spectroscopy, multivariate statistics, chemometrics chemical engineering, process systems and control engineering. It also embraces a multi-dimensional data paradigm through measuring a variety of spectroscopic, optical, physico-chemical properties in attempt to generate more process understanding that could lead to better product quality control.
In a PAT review that I co-authored in 2010 (
http://pubs.rsc.org/en/content/articlelanding/2010/ay/c0ay00257g), I noted a general lack of formal education to cater to this new trend in pharmaceutical engineering. Due to the aforesaid multi-disciplinary nature of PAT, it would be good to nurture a community of "enthusiasts" to mutually learn, support, and together build know-how and expertise to realize the potential of PAT for the envisioned 21st century pharmaceutical cGMP.
At ISPE, there is a global network of enthusiasts and experts who contribute to the general education and development of PAT. This network comprises of people from industry and academia. The ISPE PAT committee of practice (CoP) is one of the 16 CoPs promoting industrial best practices to advance pharmaceutical manufacturing (
http://www.ispe.org/communities-of-practice). Here in Singapore, a local PAT CoP is currently budding. We are starting small, with two sessions thus far having an average attendance of 20 persons. Plans to grow this local PAT CoP include regular meetings to cater for in-depth discussion of PAT topics, demonstration of PAT implementation and general networking. Keep a look out for the event details coming up for this Singapore PAT CoP!
|
Chong Hock Sia
Director (Quality Assurance) & Senior Consultant (Audit & Licensing), HSA Singapore
Firstly, congratulations on receiving ISPE Singapore's award in recognition of your services to the local pharmaceutical industry, your leadership in ASEAN and your contribution to ISPE over the years. We truly appreciate your efforts and contributions over many years.
ISPE: Your leadership in the development of the ASEAN MRA on GMP Inspection has been impressive and will be most beneficial to regulatory authorities and pharmaceutical manufacturers in the region for many years to come.
What are some of the key benefits of the ASEAN MRA on GMP Inspection?
Mr Sia:
The benefits of the ASEAN Sectoral MRA on GMP Inspection include the avoidance of duplication of GMP inspections within ASEAN, thus saving time, money and resources for both the regulator and the industry, facilitation of pharmaceutical trade within ASEAN and quicker access of medicinal products by ASEAN patients. As the international PIC/S inspection framework had been adopted as the benchmark by ASEAN, it is likely that ASEAN pharmaceutical manufacturers would become more export-oriented and globalised in their business outlook.
ISPE: Are there any further developments planned for this ASEAN MRA on GMP Inspections in the coming years?
Mr Sia: Currently, the scope of the ASEAN Sectoral MRA on GMP Inspection is restricted only to medicinal products in finished dosage forms. In the coming years, the scope of the MRA will be extended to cover Active Pharmaceutical Ingredients (APIs) and biologics. There are plans to level up more ASEAN inspectorates to become "Listed Inspection Services". Currently there are 4 ASEAN Listed Inspection Services - those of Singapore, Malaysia, Indonesia and Thailand. These 4 ASEAN Member States operate a PIC/S-equivalent GMP inspection system and accept each other's GMP Certificates without duplication of inspections. FDA Philippines has applied to be a Listed Inspection Service, and its application is pending review by an ASEAN Panel of Experts.
ISPE: What do you think is the key priority for pharmaceutical
inspectorates and manufacturers in the ASEAN region over the next few years?
Mr Sia: A key priority of ASEAN pharmaceutical inspectorates is to level up its GMP inspection system to become PIC/S-equivalent. This may be done through the PIC/S accession process or through becoming an ASEAN Listed Inspection Service. ASEAN Member States are legally obliged to accept the GMP Certificates granted by Listed Inspection Services. Increasingly, both ASEAN inspectors and manufacturers will have to pay greater attention to GMP compliance of API manufacturers, Good Distribution Practices (GDP) supply chain integrity and grapple with the issues of adulteration, contamination and falsified medicines in general.
ISPE: You have been a great supporter of ISPE over the years, especially through your contributions of technical articles to ISPE's Pharmaceutical Engineering magazine. Are you planning any more articles for publication?
Mr Sia: Yes, over the past few years, I have co-written articles for ISPE's "Pharmaceutical Engineering", covering topics such as the GMP, quality assurance and supply chain integrity of traditional and herbal medicines, APIs, pharmaceutical excipients and ASEAN GMP harmonization and training of inspectors. Future articles for publication may discuss the challenges faced by regulators around the world in balancing pre-and post-market controls for various categories of health products as well as analysing the competency of inspectors and GMP compliance of manufacturers in various jurisdictions.
ISPE: What was your observation of the sentiment/issues discussed at the recent Panel Discussion of the ISPE Singapore Conference & Exhibition 2016?
Mr Sia: With the emergence of newer technologies such as information technology, biotechnology, computerised systems and issues such as supply chain and data integrity, the industry is concerned whether inspectors will be able to cope with the onslaught of these emerging technologies. On the other hand, inspectors hope to see an industry that is consistently GMP-compliant and not to prepare for regulatory inspections based on "inspectors intelligence". I am of the view that more can be done to foster greater inspector-manufacturer collaboration for a win-win-win outcome - i.e. for the regulator, the industry and the patient/consumer.
ISPE: How do you think we at ISPE can help both regulators and manufacturers in the region?
Mr Sia: As a not for profit, international professional society with a good global reputation, ISPE can offer its collective expertise to train inspectors and manufacturing personnel, working in tandem with potential funding organizations - the latter is easier said than done, and I am speaking from experience.
ISPE: Anything else that you'd like to share with our readers?
Mr Sia: I would just like to sign off by saying that "Pharmaceutical Engineering" is THE magazine/journal for pharmaceutical professionals, in particular those involved in manufacturing, quality control and inspection!
|
 |
|
|
|
|
|
|
ISPE Soccer Tournament 2016
17 Nov 2016 | 6.30-9.30pm
The ARK @ Taman Jurong
Enter a team of 8 or join a team for this annual competition
Student Site Visit to Abbott
(sold out)
16 Nov 2016 | 1.30-5.00pm
Abbott Manufacturing (TUAS)
Biopharma Development & Production Asia Pacific Week
Mandarin Orchard Hotel Singapore
25% savings
for
ISPE Members and supporters.
Discount Code: P46321ISPE
PLUS
20 Complimentary Passes
up for grabs for ISPE Members from Pharma Companies. Email
IBClifesciences@informa.com
for more information.
Effective Pharmaceutical Audits & Self-Inspections
PQMS Auditor/Lead Auditor Course A17638
28 Nov - 2 Dec 2016
Marina Mandarin
Register as a group of 3 or more to save up to S$600 each!
This IRCA Certified Auditor training is led by UK-based NSF Health Sciences and was fully subscribed last year. Don't miss this opportunity to attend world-class education from ex industry GMP and MHRA auditors.
Registration deadline 21 Oct 2016.
19 Jan 2017
TBC
A new Executive Comittee will be elected. In case you are interested in a volunteer position, please contact
Kristina.
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.)
|
|
Foreign GMP Regulatory Inspection and Managing Changes of Licensed Facility
Hotel Royale Chulan Damansara, Petaling Jaya, Malaysia
Sterility Testing: A Risk Based Approach
Organized by ISPE Indonesia in collaboration with Bioquell and Merck
Jakarta, Indonesia
Contact ISPE Indonesia for more information
Single Use Technology in Sterile Manufacture
Best practice & emerging trends in application, operation and validation
City Convention Centre - Melbourne, Australia
Batch Record Review
Organized by ISPE Indonesia
Jakarta, Indonesia
Contact ISPE Indonesia for more information
4th Hazards Asia Pacific Symposium
|
|
|
Interested in PAT?
Join our exclusive
PAT CoP Email-List and find out about all upcoming PAT related activities.
Join our Executive Committee in 2017! Contact
Kristina for more information.
We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?
|
|
|
|
|
|
FEATURED Event
Closing Date for Registration 21 Oct 2016!
|
 Effective Pharmaceutical Audits & Self-Inspections
PQMS Auditor/Lead Auditor Course A17638
28 Nov - 2 Dec 2016
Marina Mandarin Singapore
ISPE Singapore Affiliate is pleased to invite you to an exclusive IRCA Certified Auditor Training, in conjunction with NSF Health Sciences Ltd, from the UK. This is a unique opportunity, which can lead to Lead Auditor/Auditor Certification with IRCA, saving time and travel expenses.
Auditor skill and competency are critical to making the right decisions in terms of:
* Approval of suppliers
* Approval of contractors
* Acceptability of in-house practices and procedures
* Overall regulatory compliance status
This 5 day course will provide education, training and development for auditors to meet these continuing pressures and fulfil this critical role.
Read what previous participants had to say:
"This course has given me lots of exposure and allows team discussions, presentations and exercises, which makes it much more interactive and interesting." Teo Jing Sian, Roche Singapore
"Engaging training. Pace is just right. Trainers are very knowledgable." Wang Xinqiao, GSK
"Very well organized and informative. Vey professional tutors." Ya-Ting Hsieh, Yung Shin Pharma
"Very well structured training and trainers." Shirley Chia, Novartis Singapore Pharmaceutical Manufacturing
"The course was very organised and structured. The tutors gave really good examples of all subjects. They challenged you to stay focused during the interactive sessions and lectures. I have learned a lot during this course." Thera Lardinois-Garritsen, Pharmacell BV, The Netherlands
"I would strongly recommend this course to anyone who performs pharmaceutical compliance auditing, from the novice to the experienced professional. The success of a course such as this relies on how it is structured and the abilities of the instructors. I was very impressed with the instructors, their presentation and interpersonal skills were especially good." Paul J Siciliano, Patheon Pharmaceutical Services Inc, USA
|
|
Student Site Visit to Roche Singapore Technical Operations
Thank you to Roche Singapore Technical Operations for a very insightful manufacturing tour! Organized by our ISPE Singapore Student Chapter for their fellow students, this has been a great success which we can hopefully repeat next year!
ISPE Singapore Go-Kart Challenge 2016
Our first outing at Kartright Speedway proved a roaring success. A practice session was followed by qualifying for the top 10 places. The 'Grand Prix Final' race over 8 laps was completed in under 7 minutes by the top 3 racers. Congrats to Arnaud Piffaudat who overtook Kevin Joyce in the final straight.
3
rd
place went to Derek Harnett. We look forward to next year's challenge!
ISPE APAC Committee Meeting 2016
23 Aug 2016
Prior to the annual conference, Singapore Affiliate hosted the ISPE APAC Committee meeting. We welcomed representatives from Australia, Indonesia, Thailand and Japan over 2 days of discussions. All agreed on the need and benefits of collaborating further, to grow membership and participation in the region. More news to come after the Joint Affiliate and next APAC meetings at ISPE US' annual event in Atlanta!
ISPE Singapore Conference & Exhibition 2016
Over 700 participated in the site visits, conference, workshops and exhibition this year. The impressive speaker faculty included US FDA, regional regulators and international experts. We saw 43% more visitors and 27% more delegates, with nearly 1/3 coming from outside Singapore. Overall feedback was good and we look forward to continuous improvement (which was also the theme)!
Thanks to all who participated, including our exhibitors and Sponsors, Merck, CAI and PM Group.
View photos here
Biosafety Workshop 
20 Jul 2016
Thanks to Basler & Hofmann Singapore, who brought 4 speakers to conduct this session for 27 attendees.
Sponsored by CAI, No Deviation & STERIS.
|
|
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
|
|
|
|
