SeerPharma Journal April 2015 Welcome to the first edition of the SeerPharma Journal! It’s been an exciting start to 2015 as we continue to work on an initiative to meet with you to understand your current concerns from quality and GMP perspectives. We appreciate the time that you set aside for us, and we look forward to meeting more of you soon. The Journal represents the first of many publications that will look to share the latest insights and feedback from you – our valued customer. Our Training division has been quite busy delivering courses on-site for many of our clients on a variety of topics ranging from Internal Audits for a major pharmaceutical manufacturer, to Compliance and Risk Assessment for a group involved with Cellular Therapies. We’ve also had a number of people attend our publicly scheduled course on “Introduction to GMP”. It’s clear many of you are interested in tapping into our expertise to deliver workshop style training sessions, where our consultants can work with your team to upskill and assist with making yourselves more operationally efficient. As opposed to just being a “Consultant” or a “Trainer”, you benefit from us being a hybrid of the two. SeerPharma’s software team have also had a demanding and exciting start to the new year, with a number of major government and publicly listed organisations contacting us for assistance with validating their LIS/LIMS platforms. Through our engagement we’ve come to realise that you see us as a middle person between the Science and the IT department/ supplier, and we’re proud to play that role. In this issue, we’ll share with you some of the areas of expertise that you’ve asked us to deliver on, plus a publication from the University of Technology, Sydney about our recently launched postgraduate programs for Good Manufacturing Practice. I hope you enjoy the issue! 2 | SeerPharma Journal | April 2015 www.seerpharma.com Health World Ltd look to SeerPharma to provide training on site for introduction to GMP and behavioural GMP 4 Australian medical device manufacturer approaches SeerPharma for their expertise on computer system validation 5 Global pharmaceutical company approaches SeerPharma to perform audits 6 Multinational pharmaceutical company commits to further online GMP training from SeerPharma 7 Leading Australian natural health brand implements SeerPharma GMP e-learning 7 GMP training pathways career 8 Our perspective on manufacturing in the pharmaceutical and medical device industry 9 www.seerpharma.com provides excellent SeerPharma Journal | April 2015 | 3 Health World Ltd look to SeerPharma to provide training on site for introduction to GMP and behavioural GMP Health World Limited has grown to become a market leader and one of the most trusted suppliers of Natural Medicines in Australia and New Zealand. Much of Health World Limited’s success is due to its strict adherence to its mission of helping people live happier, healthier lives. Since the company’s formation over 20 years ago, Health World Limited’s quality processes have continued to set new standards in safety and efficacy, and will continue to do so into the future. Health World Limited is Australia’s and New Zealand’s leading natural health science company, helping people live happier, healthier lives. Health World Limited approached SeerPharma to provide tailored training programs on site for “Introduction to GMP” and “Behavioural GMP”. Topics covered in “Introduction to GMP” included Manufacturers’ Obligations; Role of the TGA; GMP Principles for Manufacturing Operations; and Pharmaceutical Quality Systems. The course on “Behavioural GMP” looked to focus on how to minimise human error addressing company culture and the systems in place to influence and support changed behaviour. “The training SeerPharma has provided has been relevant, with quality content and well received by all participants. This training has improved our employees knowledge and been easily applied to their work.” Contact us if you’d like more information about how we can tailor a training program for your specific needs. “The training SeerPharma has provided has been relevant, with quality content and well received by all participants. This training has improved our employees knowledge and been easily applied to their work.” Ben Retallick, Training and Improvement Coordinator, Health World Limited 4 | SeerPharma Journal | April 2015 www.seerpharma.com Australian medical device manufacturer approaches SeerPharma for their expertise on computer system validation A major Australian manufacturer of medical devices has engaged with SeerPharma to deliver a customised program on computer system validation. The course looks to address content such as agile processes; cloud computing and automated testing and draws on SeerPharma’s experience on the regulatory (GMP) framework and incorporates case studies from the manufacturer’s work flow. The program will be delivered over one day to 25 staff and specifically addresses the manufacturer’s concerns such as : • Computer system validation across departments from Product Development, IT and Manufacturing • Electronic records and signatures • Validation life cycle processes and documentation www.seerpharma.com Contact us to learn more about our capabilities with validating computer systems SeerPharma Journal | April 2015 | 5 Global pharmaceutical company approaches SeerPharma to perform audits A US-based biopharmaceutical firm has approached SeerPharma to perform audits of their critical service providers. The company is about to undertake a phase I clinical trial in Australia of one of its therapeutic molecules. The firm utilises a variety of Australian facilities to perform clinical trials; manufacturing and formulation of their investigational product; and the final filling of product. As part of its regulatory obligations as the sponsor of the trial, the company must ensure compliance with Australian and US regulatory requirements, along with all relevant international codes of practice. SeerPharma have been requested to perform an audit of its: • CRO • Manufacturer • Finish and Fill Facility • Clinical Site • Clinical Trial Sample Storage and Distribution Provider • BioAnalytical Testing Site Contact us if you’d like more information on our expertise with auditing facilities that have an impact on your product quality. 6 | SeerPharma Journal | April 2015 www.seerpharma.com Multinational pharmaceutical company commits to further online GMP training from SeerPharma A multinational pharmaceutical company has been using SeerPharma’s web-based GMP E-learning solution for new employee and refresher training since October 2012. With additional staff coming on board, SeerPharma has altered the implementation model to provide the client with more functionality as well as the independence to self-manage the training within SeerPharma’s online Learning Management System (LMS). In addition to the automated assessments, benefits such as exception reporting for failed/ expired training activities deliver further time savings for the company so they can redirect resources to more value-adding tasks. SeerPharma E-learning GMP module 1: Introduction to GMP Leading Australian natural health brand implements SeerPharma GMP e-learning After reviewing the market with a project to replace their existing GMP induction and refresher training program, our newest client has recognised the value of SeerPharma’s GMP E-learning solution. Specifically for their implementation, they needed a training program that could be effectively integrated directly into their own LMS to ensure they maintained all training records in the same system. With 10 modules and assessments available as off-the-shelf items, SeerPharma’s GMP E-learning solution delivered on that requirement. The client was able to have the program operational extremely quickly with the added benefit of having total control of within their own LMS. www.seerpharma.com SeerPharma Journal | April 2015 | 7 GMP Training provides excellent career pathways University of Technology, Sydney (UTS) has partnered with SeerPharma, Asia/Pacific’s leading provider of technical compliance and QA knowledge, to develop postgraduate courses in Good Manufacturing Practice (GMP). Offered from 2015 as part of the UTS Graduate School of Health discipline of Pharmacy, the Masters, Graduate Diploma and Graduate Certificate courses are unique in Australia and the Asia-Pacific region. SeerPharma Managing Partner Brad Roberts says the courses have been designed to address an unmet need for industry. “The units of study cover all stages of the product life cycle from pre-clinical and clinical through to commercial manufacturing. An organisation with GMP graduates from UTS will be better placed to expand their manufacturing operations in places like Indonesia, India, Pakistan, Malaysia, Vietnam, China, Singapore and the Middle East while ensuring that they comply with the regulatory frameworks of the countries they export to.” “Graduates will have expert knowledge of Quality and Good Manufacturing Practice to meet TGA, FDA, EU and PIC/S requirements, and will have the option to specialise in a chosen stream. This gives students the flexibility to tailor their qualification to their career aspirations.” Industry based research projects supervised by UTS pharmacy academics may also be offered to students on the basis of availability and merit, helping students to build relationships with local industry. 8 | SeerPharma Journal | April 2015 Associate Professor of Pharmaceutical Science Mary Bebawy describes the courses as “contemporary and innovative; integrating research and academic rigour with the practicebased approach that UTS is well-known for.” “UTS has a strong program of research in pharmaceutical science – particularly in the area of oncology and respiratory science and the introduction of these programs will only strengthen this further. The course content is grounded in cutting-edge research, but is taught by industry based experts who have spent many years working with pharmaceuticals, biologics and/or medical device companies. To me, this is the perfect combination to empower capable, work-ready graduates – research-led but with a practice-based execution.” David Spaulding, SeerPharma Training Manager attributes the partnership to UTS’ strong reputation as being good to do business with. “We partnered with UTS because they understand the sector and they know how to work with industry.” Applications for 2015 are open now. For more information, visit: www.gmp.uts.edu.au www.seerpharma.com Our perspective on manufacturing in the pharmaceutical and medical device industry The Pharmaceutical and Medical device industry in Australia and Singapore has undergone significant change over the last decade and continues to evolve, due to a strong local currency and the emergence of manufacturing capabilities in Asia. We’ve observed a general trend for more and more companies operating as virtual companies; where manufacturing, clinical trials, packaging, logistics and distribution are being outsourced to companies in Asia, the EU, US and even here in Australia. Although this trend means a decline in out-andout manufacturing, firms are still accountable for the quality of their product and ensuring that their systems and processes are compliant to the relevant regulatory authorities in which they market and sell their products. www.seerpharma.com Our meetings with such clients have led to fruitful discussions on managing the complex paper trail created from having outsourced suppliers and the dilemma of not having authority over quality control with these entities. From these discussions, we’ve been requested to assist with auditing suppliers here and overseas. Plus provide software solutions to automate and track paper records from clinical trials, manufacturing site(s) and logistic providers. We’ve also noted a number of logistics companies approaching us for greater assistance on how to handle regulatory requirements of pharmaceutical and medical device manufacturers. These are exciting times ahead, as we evolve with the new paradigm in pharmaceutical and medical device manufacturing. SeerPharma Journal | April 2015 | 9 SeerPharma Journal Events that we will be attending in the next quarter: Event AusMedTech ARCS Congress pharmaceuticals Dates 29th - 30th April 2015 5th - 7th May 2015 Venue Pullman Melbourne on the Park Hotel, Melbourne Royal Randwick Racecourse, Sydney medical devices other industries life sciences Australia SeerPharma Pty. Ltd. Suite 2, Level 1 38-40 Prospect Street Box Hill, Victoria, 3128 Australia +61 3 9897 1990 [email protected] Asia SeerPharma (Singapore) Pte. Ltd. 10 Anson Road #20-05 International Plaza Singapore 079903 +65 6774 5800 [email protected]
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