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Article / Jun 30, 2023

Excellence in pharmaceuticals

USA Today, 30 June 2023

Manufacturing Site Ringaskiddy Cork Ireland BITCI | Hovione

Responsible for 39% of the nation’s total annual exports, the Irish pharmaceutical sector continues to expand its capabilities

 

Ireland’s life sciences sector is internationally renowned for its operational and innovational excellence, with 19 out of the top-20 global pharmaceutical and biopharmaceutical giants having a presence in the country. Overall, more than 85 pharmaceutical companies are currently operating in Ireland and the sector employs over 42,500 people. And this talent base is constantly expanding, thanks to continuous new investment into the sector. “We are the world’s third-largest exporter of pharmaceuticals and we have a good reputation for strong regulatory compliance and quality. Our regulators are seen around the world as some of the leading lights in setting standards. As a result, pharmaceutical companies in Ireland go beyond compliance, which gives them a competitive advantage,” says Paul Downing, general manager of Hovione, the leading international contract development and manufacturing organization (CDMO) that specializes in fully integrated innovative services for drug products, product intermediates and substances. 

 

PAUL DOWNING GENERAL MANAGER, HOVIONE

“Pharmaceutical companies in Ireland go beyond compliance, which gives them a competitive advantage.”

 

With state-of-the-art manufacturing facilities in Ireland, the US, Portugal and China — all of which have high regulatory compliance — Hovione has a global employee base of nearly 2,500 people and in its 63-year history has had more than 41 regulatory inspections from authorities such as the US Food and Drug Administration with no product recalls and no warning letters being issued. Something that Downing is exceptionally proud of. “We’re an expert organization with capabilities in technology transfer and new product introductions and, from a CDMO perspective, we’re recognized as a world leader in spray drying,” he says. “We’re also a progressive company and we go above and beyond compliance; we always want to learn and give our customers more, because customer satisfaction is at the heart of everything we do.” Hovione began its operations in Cork in 2009. Since then, it has quadrupled its Irish assets, client base, sales and employees, which has given it the right ecosystem to take on large customer projects. As with any industry, the digital revolution is changing all facets of the pharmaceutical business and Hovione itself has implemented a host of new digital tools at its Irish facilities in recent years. “One example of this is an electronic laboratory notebook, which is a digitalization of our core activities in research and development and our quality control laboratories. That has driven efficiency and standardization,” says Downing. “As a company, we have other global initiatives, including a plant data management system, which is a central hub for all our data on trends and information that allows us to analyze and share that data. “In addition, we’ve started to adopt a manufacturing execution system and are automating electronic batch records. That’s the journey we’re on. Here in Ireland, there are lots of advocates for industry 5.0. We’re watching that brief to see how it evolves and whether we can tap into that as well.”

 

Future growth of the biopharma industry

Ireland’s pharmceutical sector began to become an international presence in the 1960s after the arrival of pharma giant Pfizer, which was followed by names like Merck, MSD, SmithKline, GSK, Eli Lilly, Bristol Myers Squibb, Alexion and Regeneron — and by 2021, the sector was generating over $85 billion a year from its exports. Investments continue to flood in to the tune of around $1-$2 billion annually, and this could soon increase, as the association that represents Ireland’s biopharma and chemical industry, BioPharmaChem Ireland —part of the wider trade body Ibec — has recently launched a five-year strategy to further develop the sector. 

 

"We’re prioritizing skills and talent,” outlines Matt Moran, director of BioPharmaChem Ireland. “For example, we have established an apprenticeship program, which we work on with the government, that is non-traditional and vocational. In the past, companies would normally have employed university graduates, but now there is an opportunity for school leavers to work in the industry and acquire qualifications at the same time. We also operate an industry-led Skillnet training initiative, through which we arrange for training programs to be delivered to the industry to fill skill gaps. The association is also prioritizing the continued growth and competitiveness of all the sub sectors of the industry, including active pharmaceutical ingredients, biotech and finished products, states Moran, who adds: “Some of the newer areas we’re exploring at the moment are pharma 5.0, which involves empowering employees as well as deploying technology, sustainability in manufacturing, cell and gene therapies and very advanced therapeutics. We also want to grow our indigenous base of startups and to expand our footprint to include additional aspects of the industry, such as global business services, clinical research and more engagement research. That’s the future.”

 

Read the full article at BusinessFocus.org

 

 

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Key Takeaways Multiple departments, including engineering and quality assurance, are responsible for evaluating GMP equipment and facilities. Regulatory inspectors require well-organized, preferably digital, maintenance documentation during GMP audits. A computerized maintenance management system (CMMS) is crucial for tracking maintenance activities and ensuring high performance. Common mistakes include neglecting criticality assessments, relying solely on time-based maintenance, and failing to consider maintainability during design. Adequate commissioning time is crucial for equipment lifespan and maintenance reliability. Construction and maintenance of manufacturing buildings and equipment fall under good manufacturing practices (GMPs) regulations (1–5). Pharmaceutical manufacturers can comply with these rules in the form of risk-based maintenance programs. Pharmaceutical Technology® spoke with David Basile, VP Technical Operations, Americas, Hovione, about how companies can meet these requirements for GMP facilities and equipment and some of the common mistakes made when working toward compliance. PharmTech: Which department is responsible for evaluating GMP equipment and facilities? Basile (Hovione): The primary groups that participate in the evaluation of GMP equipment and facilities are engineering, maintenance, while quality assurance (QA) oversees compliance and approval. The best companies keep a few dedicated roles focused on maintenance planning and equipment reliability to drive best practices and implement the concepts of reliability centered maintenance. Do regulatory inspectors request proof of maintenance? If yes, how should this be compiled and presented to the agency? Yes, it's fairly standard for regulators to request proof of maintenance during GMP audits to verify compliance and confirm that we document all our activities related to the manufacturer and release of our products. You didn't do it, if you didn't document it. We compile detailed electronic records, including preventive maintenance schedules and calibration certificates. These should be presented in a clear and organized manner. In our recent inspections, we've seen that inspectors appreciate being able to get these records in a digital format for portability, and in case they'd like to reference them at their convenience. Another element here is using what we call our computerized maintenance management system, or CMMS. This is a central repository for all of our maintenance-related activities. This is a key system in the efficient execution of any strong, compliant maintenance program. It provides detailed work order history, preventative maintenance instructions, asset specifications, scheduling, data and spare parts inventory, so we can see trends and pick up drift, for example, to clearly demonstrate that our assets remain in a state of high performance and quality operation. We'd really be flying blind without a CMMS. It's a tool that you can't live without in today's world of pharmaceutical maintenance. What are the most common mistakes that manufacturers make when it comes to maintaining GMP equipment and facilities? Failing to do a comprehensive criticality assessment and a risk-based approach, [which can result] in over or under maintenance [is one mistake]. Solely relying on time-based preventative maintenance versus proactive maintenance approaches such as precision alignment or lubrication [is another]. Today's teams need to incorporate conditions-based maintenance using technologies such as vibration analysis. They can no longer just fix things that break. They need to diagnose equipment, looking for early signs of failure before they fully develop. Other examples of this are ultrasound or infrared scanning to ensure motors and electrical systems are wired and operating properly. Another mistake might be failing to consider design for maintainability during upgrades and not during the design phase. Adequate space and access to equipment, standardized tools, having the right pickups on equipment for condition-based maintenance [are important considerations]. I can't tell you how many times I've seen a filter housing or an instrument placed in the interstitial space above a ceiling with no way to safely access it. Failing to consider design for maintainability and not bringing maintenance in during the design phase is one mistake that people often make. Not carving out a role for a dedicated maintenance planner is also a misstep. At Hovione, we have a dedicated reliability engineer and maintenance planner that help in the evaluation. This is critical to shorten the mean time to repair and ensure that all tools and supplies needed for the job are available and kitted to support fast first-time-right work order execution. These roles are game changers to the operation and take you from walking to sprinting, especially when candidates bring hands on experience. In fact, the best planners are usually seasoned mechanics. One final failure we see often is not building in enough time for commissioning. The lifespan of equipment can be greatly influenced during the commissioning phase. This is where maintenance reliability starts. Too often, commissioning is rushed through, and equipment and preventive maintenance plans and required spare parts are not thoroughly assessed. In many cases, due to limited time, the CMMS system is not fully populated with key information to perform comprehensive root cause analysis. 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