A little bit about myself… I qualified as a pharmacist from Trinity College Dublin in 1983 where I also obtained a research M.Sc. in Science, working in the area of pharmacognosy. I am passionate about enabling the availability of high-quality medicines to the public. I have over 30 years’ work experience divided between the pharmaceutical industry, as a regulator of the industry and as a consultant to the sector. My experience spans quality and regulatory compliance (GxP) across the product lifecycle from product development to commercialisation. I previously worked as Senior Inspector with the Health Products Regulatory Authority (formerly the Irish Medicines Board) and inspected nationally and internationally on behalf of the EMEA for GxP compliance. I have actively participated at a national and international level in initiatives impacting the healthcare area including the development of legislation and best practice guidance impacting the pharmaceutical sector. My company McGee Pharma International has successfully helped advice and support pharmaceutical companies develop, manufacture and distribute medicines safely for over 14 years. McGee Pharma International has now a new identity as we become part of the PharmaLex Company and will have completely re-branded by February 2018 to PharmaLex Ireland. We are very proud of our heritage and reputation and it remains key to our success over the past 14 years. As part of the PharmaLex Group, we will be able to offer an expanded suite of services to our clients, present and future. The standard and quality of our services will remain unchanged and we will strive to continue to provide excellence in regulatory compliance. My tips on building a strong quality culture within the life sciences industry… “A culture of quality is one in which everybody in the organisation, not just the quality controllers, is responsible for quality”. Maintaining a leadership emphasis on quality: We must all remind ourselves on a daily basis that we are developing, manufacturing, testing and distributing medicines that ill people will take with an expectation that the medicine will treat their symptoms or cure their illness. Quality is not an option, it is an imperative. A culture of quality is one where product quality is at the heart of every business decision we make. Even when Management has the best intentions, there are often gaps between what they say and what they do. As a result, employees get mixed messages about whether quality is truly important. Management must demonstrate its commitment to the mission of building a culture of quality. This will send the message to employees that quality is key to success in an organisation. Management should develop quality metrics for themselves and the staff. Walking through the manufacturing plant, talking with employees, viewing daily operations should take place regularly. Employees will see that leadership is serious about quality. Data and suggestions gained from these walks should be acted upon if they involve improving processes, employee morale, or compliance in general. In addition, continuous improvement activities can be fostered and encouraged throughout the company. The mentality of the ‘everyone owns quality’ should be emphasised continuously by the leadership team. A mentality of “we’re all in this together” (the company, suppliers, and customers) is key. Consider quality initiatives such as Quality Councils and quality promotional weeks to maintain focus on product quality. Quality Councils to review quality improvement opportunities and meaningful quality metrics can be very effective in promoting a positive quality culture. In all interactions, leaders must promote and prioritise the culture values such as moving to a ‘no blame’ culture and focusing on the improvement opportunities, ensuring information is accessible and that open honest communication is promoted. Ensuring that policies and procedures are in line with regulatory requirements is another important element to embedding quality in your culture. Policies need to be clear. Procedures need to be easy to understand, yet detailed enough to make sure the process can be implemented consistently. Cut down on the wordiness of documents to help the staff better understand the process, making them more efficient and ultimately more compliant. Appropriate and effective training of personnel is critical to enable business effectiveness and efficiency. This is Management’s responsibility. How effective is ‘read and understand’ training? Can I implement that activity after such training? If not, that is simply not good enough! “We are what we repeatedly do. Excellence, then, is not an act, but a habit”. My secret to driving change through challenging times… A strong and positive quality and company culture can help companies achieve change and build organisations that will thrive through the ups and the downs. I believe in valuing my team and empowering them to embrace change to weather the storm through challenging times. My secret to becoming a true partner to our clients… Three key things:
- Focus on exceptional communications
- Keeping clients informed with an update ‘before’ they think to ask for it
- Exceed expectations
The biggest challenge facing my industry today… Brexit – We are entering a period of significant uncertainty. In theory, nothing should change until 29th March 2019. However, the industry is at risk from Brexit, border delays, R&D disruption and regulatory divergence will pose hazards to the industry. The industry is under strong pressure to drive down the cost of medicines. The uncertainty associated with Brexit will add another layer of complexity to that challenge which is ultimately about making medicines available to the public at an affordable price while ensuring the financial return to the industry can continue to fund groundbreaking research to bring new and even better medicines to the marketplace. The greatest opportunity available to our industry today is… The pharmaceutical industry has experienced a significant globalisation of the supply chain over recent times. Outsourcing is gaining increasing popularity and plays a key role in today’s medicines production and distribution. Regulatory authorities are increasingly sensitive to the potential supply, patient safety, and compliance issues associated with complex supply chains. There is a focus on ensuring that suitable control and management oversight systems exist and ensuring that the systems are consistently applied. Introducing external third-party links in the supply chain increases complexity, as communications pass back and forth involving different time-zones, cultural, and language barriers. Complexity increases the risks to security of supply, quality, and compliance. PharmaLex Ireland understands the complexities and the interplay between the multiple factors. We can help our clients set up and manage this globalisation shift, enabling confidence beyond compliance. My view on key concerns to look out for moving into 2018… Pharma companies need to anticipate the possible consequences of Brexit and work on putting in place a contingency plan for their regulatory strategy and supply chain to ensure the company is ‘BREXIT-ready’ The EMA has warned about a possible disruption in its operations. In addition, there are many other regulations that will come into force in the sector within the next few years, the consequences of which need to be anticipated e.g. Annex 21 to the EU GMP, Medical Devices Regulation, Clinical Trials Regulation, Annex 1 updates etc. On a lighter note, if you could step into the shoes of one person for the day, who would it be and why… This is challenging! I admire many people, eminent and unknown. People who exude wisdom and serenity impress me most. Currently, their shoes are too big for me to fill, but I’m working on that! This article written by David Phelan was originally published on Accreate.com on 6/2/2018. View the original article here.