In a career spanning almost 50 years, Joseph Manfredi of GMP Systems has helped some of the world’s best known pharmaceutical companies deliver their products to market. Following his success in the Business Worldwide Magazine CEO Awards 2022, here we learn about his exceptional work in his field.
Globally, the regulations and enforcement associated with pharmaceuticals is typically the responsibility of regional entities such as The European Pharmacopeia (Ph Eur.) and EMA (European Medicines Agency). In America, the situation is similar but is often more challenging. All drug products are heavily regulated by the USP (US Pharmacopeia) with related enforcement by the FDA (US Food and Drug Administration).
Bringing drugs to market is a long and complex process, which is notoriously hard to navigate. Led by founder Joseph Manfredi, GMP Systems uses an innovative blend of science and technology, combined with quality engineering, design and advisory services to help facilitate the manufacturing process for its customers.
Based in New Jersey, the company is renowned for its exceptional customer service. Mr Manfredi and his team have proven time and time again that they are driven by helping clients get their systems validated and qualified as quickly and efficiently as possible.
Fifty Years of Innovation
Joseph’s impressive career spans nearly 50 years. During that time, he’s gained a reputation as a leader in his field. His work involves designing systems, overseeing fabrication and installation, troubleshooting, training and consulting for most of the world’s major pharmaceutical and healthcare manufacturers.
A graduate of Newark College of Engineering (NCE) at New Jersey Institute of Technology (NJIT), Joseph’s experience includes all aspects of liquid processing with special emphasis on pharmaceutical water and steam systems. Other areas he’s used his extensive expert knowledge in include the safe and efficient production of ointments, creams, syrups, pastes, gels, tablets, tablet coatings, suppositories and numerous other formulations.
As a leading instructor of orbital welding technology for pharmaceutical, cosmetic, food, beverage and personal care applications, he also provides seminars for operator certification, orbital weld inspection, and equipment calibration and service. One of his many achievements; Joseph was the driving force behind the establishment of a Master of Science Degree program in Pharmaceutical Engineering at New Jersey Institute of Technology. There he developed and taught many of the initial core curriculum courses as a member of the graduate faculty, as well as serving as Chair of their Pharmaceutical Engineering Advisory Committee. While teaching, as a member of the graduate faculty, he developed and taught “Principles of Pharmaceutical Engineering”, Pharmaceutical Facility Design”, and “Design, Operation & Validation of Pharmaceutical Water Systems”.
As a member of many professional and industrial associations including PDA, ISPE, AWS, ASSE, ISO/AWWA and NJBIA, Joseph has often been chosen to lecture and lead courses both domestically and internationally. He currently serves on the ISO Technical Committee TC-282.
A Leader in His Field
Joseph’s credits also include an extensive list of published book chapters, papers, presentations and other technical work. He has been heavily involved with many of the ISPE guidance documents including the Water and Steam Systems Baseline Guide as well as Good Practice Guides for Ozone Sanitization of Pharmaceutical Water Systems, Sampling for Pharmaceutical Water, Steam and Process Gas and Membrane-Based Water for Injection Systems.
The recipient of numerous awards, he is a current member and past chair of the ISPE Critical Utilities Community of Practice Steering Committee, is a past recipient of the prestigious ISPE Member of the Year Award and was honoured as an NCE Distinguished Alumnus on multiple occasions.
GMP Systems’ turn-key solutions are diverse and far reaching. The company is best known for pharmaceutical water systems, but Joseph and his team’s comprehensive knowledge extends to virtually all liquid or gaseous processes, ranging from the manufacture of household cleaning products to brownie batter.
At the heart of all GMP Systems work is a stringent documentation process, meaning that all their designs and installations are guaranteed and trusted for their reliability, integrity and exemplary work quality.
Critical utilities used in pharma manufacturing include water, steam, and process gases. Water is the single largest volume material used in production of pharmaceutical products (water can facilitate manufacture, become an ingredient or be the product itself) with strict requirements for both chemical and microbiological purity. Pharmaceutical grades of water include USP Purified Water, and USP Water for Injection (WFI).
GMP Systems’ comprehensive understanding of the industry regulatory requirements, as well as the associated enforcement policies and practices helps its clients throughout the design, construction and implementation of new systems. That information must be appropriately interpreted and integrated into design documents and then applied throughout construction to allow for a properly validatable system.
GMP Systems offers a comprehensive suite of services, including:
Design and Consulting
Dedicated designers and engineers work in close collaboration with GMP’s customers before designing bespoke, highly customised systems from URS through installation to IQ/OQ and PQ Execution.
Fabrication and Packaged Equipment/Skids
A full design and skid fabrication service is available, ranging from large multi-section skid units to small portable devices. Systems are available fully wired and piped with pre-programmed controls to meet client needs. All details related to fabrication including welding, polishing, machining, assembly and testing can be made available.
Turn-Key Systems and Field Installation
The turn-key design-build approach to systems allows clients to fully utilize the complete range of expertise available from GMP Systems technical staff. As well, during project installation and beyond, GMP System’s expert crews meticulously utilize computerized autogenous orbital welding systems, supported by precision cutting and facing equipment, and inspection/monitoring devices.
Custom Design & Fabrication
Every client has different needs, which is why GMP Systems offers a bespoke service that can be tailored to virtually any application. Design and fabrication services range from fully automated self-contained process systems to portable equipment such as pumps and filters to hose reels, speciality fittings and adapters; jacketed tubing and manifolds, and much more.
Service and Maintenance
Full support and maintenance is available throughout the entire lifecycle of all GMP System’s solutions. Their systems and components can all be provided with installation, repairs, after-warranty maintenance and staff training. Most systems are still fully functional more than 20 years after installation, which is testament to the team’s skill and dedication to quality assurance.
Commissioning, Validation and Compliance
The road to regulatory compliance is a long one, so GMP’s customers have the option of comprehensive support throughout the entire process, from start-up and commissioning to validation executions leading to process compliance. Regular audits can also be provided, along with detailed reports and recommendations for best operational and maintenance practices.
Training and Education
The company offers a full complement of training service to help users get the most of their systems and machinery and ensure they’re using it as safely and effectively as possible – an important part of compliance. GMP’s education program can also be customized to cover practically any related topic with extended detail.
In addition, Joseph continues to teach courses in all affiliated topics lecturing for PDA, ISPE, AWS and Interphex. His client list for consultation, design and completed systems includes most major pharmaceutical manufacturers, as well as many Fortune 500 firms.
Speaking to Business Worldwide Magazine, Joseph explained what makes GMP Systems a cut above the competition.
“Our system documentation is the best in the business. We have proven multiple times that we are dedicated to ensuring the customer has the best possible system that will meet FDA and other global regulatory standards. Our reputation has been built on quality and our commitment to provide excellent service, including long-term support.”
To find out more about GMP Systems, its products and services, visit the company website at www.gmpsystems.com