We're now past the mid-year point with 2/3rds of our events held and the Big Ones to come! This year's Singapore Affiliate conference and exhibition will be bigger and better than ever, with an exclusive Patient Perspective, more regulators, pharma and biologics manufacturer speakers and a sold-out exhibition among the highlights.
Also new this year, we're excited to bring the first joint ISPE US Asia Pacific Conference on GAMP Data Integrity in November. This hot topic reaches our shores with an interactive, thought-provoking and in-depth programme which will deliver key takeways across your organisation.
Plus more socials, workshops and opportunities to learn and connect with your peers.
We look forward to seeing you in August, September, October....etc!
Best Regards,
your ISPE Singapore Affiliate
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Maurice Parlane
ISPE 2016 Member of the Year; Past President, ISPE Australasian Affiliate, past chair of the ISPE Asia Pacific Affiliate Council and Director of Centre for Biopharmaceutical Excellence Pty Ltd, Australia
We are in a period of change which is unprecedented in the time I have worked within this industry. Requirements for manufacturing companies to focus on science and risk based understanding cannot be met if we continue to work in the way we have. More than ever it is important to empower all functions within a business to understand and practice quality risk management. This brings with it a challenge to communicate product knowledge and process understanding and to ensure teams supporting projects and manufacturing operations are equipped with the tools to "walk the talk" of science and risk based practices.
Walking the talk is where risk assessments and subsequent actions and decisions reflect the real risks in products and processes and bring about changes in the way we do things. For too long now industry has "bolted" risk assessments on to products which are used to validate doing things in the same way as we always have. They exhibit a bias reflecting the way we have worked in the past.
Effective transfers or product introductions and subsequent operations must focus more on clinical relevance and patient consequences. The key to this in my opinion lies with understanding criticality, not risk scoring. Most organisations use FMEA or FMECA tools to direct their QRM efforts and these tools can mask criticality. Don't take me the wrong way - there is nothing wrong with the tools, it's the direction we are pointing them in...Who in a project or manufacturing setting truly understands clinical relevance or patient consequence of products? I'm certainly not an expert in this area and how is this knowledge typically transferred into the QRM effort in projects or a manufacturing setting?.
If we are to be effective in delivering projects and making safe and reliable products we need to have a clear focus on the relative criticality of product quality attributes. Not all present the same risk; yet we tend to think of them in a binary way - Critical or not critical. The degree of actual criticality needs to be reflected in our qualification, validation and manufacturing operations if we are to be more effective.
This is the role of the Control Strategy - a new phrase entering the GMP vocabulary. Control Strategy is not simply a validation deliverable as part of a project which is filed away in the way some risk assessments have been.
Control Strategy is central to communicating current understanding of product and process requirements and should be a living document that is refined as this understanding is enhanced. An effective Control Strategy captures knowledge at the various phases of the product's life, allowing staff to direct their efforts effectively.
A well thought out and reasoned Control Strategy is the key to "walking the talk" of QRM in my opinion. It is imperative they do not become just another "quality document" at the front of a project. Good Control Strategy will be simple to understand and will be invaluable to building product and process understanding for project and operational staff.
Warm greetings, everyone!
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Interview with...
Paul Si
Head Project Management Asia, Novartis Singapore Pharmaceutical Pte Ltd
ISPE SG: From your varied experience in the region, could you share with us some highlights of your career so far?
PS: I have over 21 years of industrial construction project experience with 11 years of experience in the Life Sciences sector. Before joining Novartis, I was working in Sarawak, Malaysia for 2.5 years as Project Director of a 944MW hydroelectric dam project. My other major green field project experiences include REC, GSK Bio and Schering-Plough.
ISPE SG: Regarding the industry and your current role, what do you consider the biggest challenges that you face?
PS: It is no secret that in recent years there has been a lot of pressure on the cost of drugs in the pharmaceutical industry. Hence the challenge for my team and I is to deliver projects in the most cost effective and timely manner possible.
ISPE SG: What do you enjoy most about being and/or working here?
PS: My current role in Novartis grants me many opportunities to interact with colleagues around the region which I enjoy a lot. I am also provided a strong platform and team oriented environment for me to use my project management skills and experiences in a different capacity from what I had in the past.
ISPE SG: Is there anything that you'd like to share with our readers?
PS: I feel that we are at a unique moment in the development and manufacturing of new drugs. On one hand, there can be improvements in the costs and time taken for new drugs to successfully reach patients. However on the other hand we are also seeing breakthroughs in drug discovery and advanced manufacturing, plus unconventional approaches to pricing models and strategies around innovation. I believe that with the help of new technologies the drug development process will be accelerated and costs lowered. Hopefully this happens sooner rather than later.
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Did you read...
The Draft Q&A to Electronic Records and Signatures in Clinical Investigation aims at encouraging and facilitating the use of electronic records and systems to improve the quality and efficiency of clinical investigations.
Are you ready for implementation of ICHQ3D By December 2017?
View Article
Can pharma companies cope with current demands in meeting the needs of a wide swath of consumers?
View Article
Are you ready for the impending FDA/ICH Q11 guidance?
View Article
Will you be looking back at your Quality System after reading this?
View Article
Are stringent requirements for Excipients really needed?
View Article
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ISPE Singapore Conference & Exhibition
23-26 Aug 2017
With regulators and case studies from regional manufacturers. View the final programme and register with special and group rates!
ISPE Singapore Go-Karting Challenge
NEW! Open to members and guests on Full Track (transport provided). Non-racers are also welcome to cheer competitors on! (All racers must present their driving licence)
Limited Places: Register today!
Thirsty Thursday with ISPE!
5 Oct 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 is pleased to be supporting this event in judging the awards.
Pharmaceutical GMP Course
30 Oct - 1 Nov 2017, 9am-6pm
Early Bird Rates extended to 30 July! Book your place today!
Led by 2 lead trainers from UK based NSF, this comprehensive course will be the first-run in Asia.
ISPE GAMP Data Integrity Conference
13-14 Nov 2017, 9am-5pm
Save these dates for the first joint event with ISPE USA on the industry's current hot topic!
This 2 day regional conference will feature international and regional speakers and authorities. Watch out for more details soon.
ISPE Singapore Soccer Tournament
Nov/Dec 2017
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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ISPE Australasia DI Utilising GAMP
27 Jul 2017,
Auckland, New Zealand
ISPE Philippines Seminar-Workshop on CAPA Management
11/12 Aug 2017, Crowne Plaza Hotel, Quezon City
ISPE Thailand
Annual General
Meeting 2017
16-18 Aug 2017,
Ambassador Hotel Bangkok
Topic: Pharmaceutical Manufacturing Facility for the Future
ISPE Indonesia HVAC and Water System for Pharma Industry led by
Gordon Farquharson
21/22 Aug 2017,
Titan Centre, Tangerang, Indonesia
ISPE Philippines Seminar on PIC/S updates and Project Management
14/15 Nov 2017, Crowne Plaza Hotel, Quezon City
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Challenges and Advances in Cleaning Ultrafiltration Membranes used in Bioprocessing
by Beth Kroeger, Paul Lopolito, Thomas Smith and Amanda Deal
INTRODUCTION
Concentration/Ultra-filtration (CUF) membranes are used extensively in biopharmaceutical operations. A typical purification platform may incorporate two to six CUF steps throughout the downstream process. Customarily, these membranes are cleaned using 0.1 - 0.5 N Sodium hydroxide (NaOH), dilute solutions of Sodium hypochlorite (NaClO) and possibly elevated temperatures. (1,2) These solutions are chosen due to recommendations from the membrane manufacturer or what has been historically performed on site.
The cleaning process is challenging and does not make allowances for the residue being cleaned, only the compatibility of the cleaning agent on the membrane. By not considering the residue and how to effectively remove it from the surface, the end user is left with an inefficient cleaning process at best. Inefficient cleaning of CUF membranes leads to a reduction in membrane cycles, or re-use rate, increased water consumption, lower product yields, increased risk for microbial contamination and an increase in concentration/ultra-filtration processing times.
Proposed is a method to evaluate formulated cleaning agents commonly used on stainless steel surfaces for cGMP cleaning applications to demonstrate they may also be suitable for cleaning select CUF membranes. Using select formulated chemistries to clean UF systems instead of NaOH should translate into longer membrane lifetime, faster processing times while the membrane is in operation and require on average 40% less rinse volume to flush system back to baseline when compared to a typical rinse volume requiring on average 50L of WFI/m2 surface area.
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ISPE Singapore Quiz Night
Our most popular social moved West to Twenty15@Bigbox and attracted over 80 competitive participants. Congrats to the team from HGP!
Process Validation (PV) Workshop: Life Cycle Management & Risk Based Approaches
This 1 day intensive workshop was attended by 40 attendees with rave reviews. Watch this space for dates next year!
Student Chapter YGen 2017
Held at NUS, the revamped and expanded YGEN 2017 featured sharing sessions from industry and young professionals, fun and games. Kudos to the Student Committee for its best event ever, with close to 60 enthusiastic participants.
Introductory Workshop to Biosafety
6 July 2017
Thanks again to Basler & Hofmann, who provided new insights and learning for over 25 professionals.
Thirsty Thursday with ISPE!
6 July 2017
A new and informal social held in Jurong East, attended by over 50 members and friends from bio/pharma manufacturing.
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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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