SeerPharma is a consulting firm that has existed for over 30 years, assisting companies in the Asia-Pacific region conducting steps in manufacture of life-saving pharmaceuticals/medical devices on matters of Quality Assurance and GMP compliance. Quality impacts every step of manufacture from API to fill/finish for pharmaceuticals, design and development for medical devices, to packaging, labelling, logistics and warehousing. We’re passionate about Quality, as we know the work we do with our clients, plays some small part in ensuring the safety, efficacy and quality of product administered to patients the world over.
Part of this mission has led us to be associated with major international networks who share this same vision. One being, the International Society of Pharmaceutical Engineers (ISPE), the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. We’re proud to have one of our very own Senior Consultants – Helen Atkinson, hold the position of President of the Australasia Chapter of the ISPE. Helen recently attended the 2019 ISPE Annual Meeting in Las Vegas, Nevada, and below are her thoughts on this amazing event.
Two weeks ago, in my capacity as President of the ISPE Australasia Affiliate, I had the opportunity to attend the ISPE Annual Meeting for 2019 in Las Vegas. Whilst my main agenda was involvement in the ISPE Joint Affiliate Council Meetings (Global and APAC Regional) to collaborate, reinvigorate and unveil the new strategic goals for the global organisation, I was privileged to be able to attend two of the plenary sessions. The topic this year was Modernize, Globalize, Transform.
With a great line up over 6 different streams, the conference focussed on the changes that we are seeing in our industry in not only manufacturing techniques but also the regulatory landscape. With over 2000 people in attendance the opportunities to learn, network and gain a wider industry perspective was amazing.
Two of the keynote speakers reminded me of why we do what we do in our industry.
Jessica H spoke as a Patient Advocate. Her story shows a fit and athletic young woman with her life ahead of her, being given the news she has MS. The drugs that she takes, which our industry has developed and produced, have enabled her to carry on with a “normal”, albeit her “new normal”, life.
John Crowley, Chairman and CEO, Co-Founder, Amicus Therapeutics, shared his story in “When Drug Research is Personal: A Lifetime Journey to Discover, Create and Manufacture Medicines for Rare Diseases.” John’s two children were diagnosed with the rare Pompe disease. The need to find a cure drove the research agenda and his personal connection with “the patient” drove the need to do this with the utmost care. As a mum I know I would do anything I could to protect my children.
We must always put the patient first and foremost in our minds. The patient, your friend, your parent, your child, deserves your care and attention in all aspects of your job. The patient often relies on the output of our jobs, not only to feel better, but to survive.
The patient needs it now. The patient will not get the product they need. These are common phrases which can be heard in the commercial environment. Everyone has the patients' best interests at heart, after all we work in an industry which is making a difference to peoples' lives every day. In Quality Assurance we must stand strong in ensuring that they not only get the product they need, but we can guarantee the product is of a quality we would be happy to give our loved ones.
How simple would it be, in the busy world of manufacturing, with capacity constraints and pressures of “just in time” supply chains, to use the “patient first” requirements in order to justify a quick release of product with inadequate investigations of deviations? How easy would it be to justify missing a significant root cause or incorrectly justifying something which has a potential product safety or quality impact by telling ourselves we are putting the patient needs first. After all if I do this we’ll meet the release deadlines.
With rapid changes in the manufacturing technologies, increased automation, advances in data collection capabilities and use of rapid testing to enable continuous monitoring through the product lifecycle we are entering a new phase in the pharmaceutical industry.
I came away from this meeting with a reignited passion to ensure that we place the right level of “quality” in our businesses. The emphasis on building a strong quality culture is key to ensuring the Patient is truly put first.