Resolving compliance issues for skin care products

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

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

A representative of GOJO Industries portrayed the company's experiences in complying with the findings of a recent FDA audit of its 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.

"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 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 its systems and procedures, it was evident that additional efforts to enhance the compliance programme were required.

GOJO was re-inspected in 2003.

The programme and progress were satisfactory and did not result in any additional action.

The presentation took place in Copenhagen at the World Drug Summit.

It describes how GOJO and the Invensys team worked together to enhance and strengthen systems and procedures.

The lessons learned from the experience and insights on 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 available to discuss 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 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.

The World Drug Manufacturing Summit is organised 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 and logistics and human resources.

For more information visit the website wdm.worldtradeco.com.

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