Press Room

Article / Mar 17, 2017

Hovione establishes presence in Osaka

JETRO, March 17, 2017

Hovione, an established Portuguese pharmaceutical company, has opened a representative office in Osaka in June 2016 and now established Hovione K.K. in February 2017.

The company has been engaged in R&D and manufacturing of drug ingredients and compounds for more than 50 years since its foundation in 1959. Its strength lies in its expertise and advanced technology in areas such as inhalation development. It has expanded manufacturing sites in the US, Macau and Ireland. In Japan, Hovione distributes their Active Pharmaceutical Ingredients (API) for generic drugs to major pharmaceutical companies via sales agents, and it is also engaged in contracted development and manufacturing development as well as the particle engineering.

Hovione plans to apply for a license of Marketing Authorization Holder (MAH) and to obtain additional sales approval of its API.

For the establishment of Hovione’s base in Japan, the JETRO Invest Japan Business Support Center (IBSC) provided support such as consultation (corporate registration, labor affairs and tax matters) and invitation to Japan to assist the establishment of the base.

JETRO

 

ポルトガルの製薬会社Hovioneが大阪に進出

ポルトガルに本社を置く、老舗製薬会社であるHovione が2016年6月、大阪に日本駐在員事務所を開設し、 2017年2月にホビオン株式会社を設立した。

同社は、1959年の創業以来50年以上にわたり、原薬や化合物の研究開発と製造を行っており、特に吸入剤などの分野で高い技術を持っている。海外では、米国、マカオ、アイルランドにも製造工場を保有。日本では、代理店経由で大手製薬会社を対象に主にジェネリック医薬品(後発薬)向け原薬販売を行っているほか、受託開発製造、粒度設計などにも従事している。

今後は日本法人の医薬品製造販売認可や日本で販売する原薬の追加承認申請等を進めていく。

日本拠点設立に際し、ジェトロ対日投資・ビジネスサポートセンター(IBSC)は、拠点設立にかかるコンサルテーション(登記・労務・税務)、個別招へい等支援を行った。

JETRO / ジェトロ

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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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