GOJO Industries presents experiences in resolving compliance issues for OTC skin care products

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Case history describes how an Invensys Validation Technologies team helped GOJO design and implement a comprehensive validation approach and improve manufacturing processes

Invensys plc announced that a representative of GOJO Industries, a leading global supplier of skin care products, described the company’s experiences in complying with the findings of a recent FDA audit of GOJO’s manufacturing operations. In a presentation entitled “Surviving an FDA Audit – Speaking the Right Language”, GOJO Industries Vice President Supply Chain, Dr. Marcel Olbrecht, described how GOJO resolved compliance issues with the help of Invensys Validation Technologies. The presentation took place on October 6th at the World Drug Summit in Copenhagen.

“Every hour that we were out of compliance was an hour that our business was at risk so measures to achieve regulatory compliance were a top priority for GOJO. We were committed to putting the necessary resources in place to resolve the “483s”. The Invensys Validation Technologies people were right there with us, putting in long hours and providing guidance and techniques that helped get our programs completed, on budget and within the deadline,” said Dr. Marcel Olbrecht, Vice President Supply Chain for GOJO Industries.

Based in Akron, Ohio, GOJO introduced the World’s first waterless hand cleaner in 1946. In the late 1990s GOJO introduced PURELL®, which became the leading instant hand sanitizer. In February of 2002, after an FDA audit of the systems and procedures, it was evident that additional efforts to enhance the compliance program were required. GOJO was re-inspected in 2003 and the program and progress were satisfactory and did not result in any additional action.

In the presentation, Olbrecht described how GOJO and the Invensys team worked together to enhance and strengthen the systems and procedures. The lessons learned from the experience and insights on how ISO and Current Good Manufacturing Practices (cGMP) standards put forth by International Society for Pharmaceutical Engineers (ISPE) will also be discussed.

Andre Charriere, Vice President - International, Invensys Validation Technologies, was also there, discussing the project and Invensys’ complete range of services providing validation support in accordance with all current GMPs, GLPs, GCPs, 21 CFR Part 11 (electronic records and signatures), ISO and other global guidelines and regulations from the EU, United Kingdom, Japan, Singapore, Canada, and other regulations, as well as our client specific standards and expectations.

Mr. Charriere also discussed Invensys applications that support Process Analytical Technology (PAT) solutions involving new on-line sensors, control system integration and process automation; validation, consulting and regulatory solutions.

“We not only deliver solutions, we go one step further. We develop very close relationships with our customers, and form more than just a partnership. We help them make continuous improvements. Our solutions continue to evolve along with technologies and regulations. We improve manufacturing efficiencies and reduce the costs to our clients,” said Mr. Charriere.

About the World Drug Manufacturing Summit

The World Drug Manufacturing Summit is organized by London-based World Trade Group, which offers residential business summits combining the best elements of a conference, exhibition and targeted networking event. The World Drug Manufacturing summit brings manufacturing, operations and supply chain professionals from the world's leading pharmaceutical and biotechnology companies together with premier raw material, technology, equipment and service providers. In addition to drug manufacturing, summit topics cover drug discovery, financial services technology, e-commerce, finance, supply chain & logistics and human resources. For more information visit the website http://www.wdm.worldtradeco.com .

About Invensys Validation Technologies (IVT)

Invensys Validation Technologies is a recognized leader in global regulatory compliance, validation, engineering consulting and vendor/platform independent integration services and solutions for the pharmaceutical, biotechnology, cosmetic, contract and device industries. IVT provides regulatory-compliant process solutions, system integration, PAT solutions and collaborative engineering to reduce time to compliance and operating costs, while improving quality and operational efficiency across the supply chain. For more information about Invensys Validation Technologies visit http://www.invensys-vt.com.

Invensys plc. (http://www.invensys.com) is headquartered in the UK and is listed on the London Stock Exchange. With 35,000 employees operating in 60 countries, Invensys helps customers to improve their performance and profitability, building value for end users and shareholders alike.

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Invensys, Invensys Validation Technologies are trademarks of Invensys plc, its subsidiaries, or affiliates.

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