Conrad Mutschler, Vice President, Global Supply Chain Strategy, Perrigo Company plc, opened the first Manufacturing and Operational Excellence education session on June 8, 2016, at the ISPE/FDA/PQRI Quality Manufacturing Conference on June 6, 2016.  The first of three presentations, Mutschler discussed “Building and Sustaining a Culture of Continuous Improvement.”

Perrigo is a global health care supplier with a presence in more than 80 markets. With over 30 operating locations and 13,000 employees around the world, its global culture creates both diversity and complexity.

A Continuous improve culture presents still more challenges—and more opportunities. But while the concept of continuous improvement may be different in other industries, continuous improvement is what we do in the pharmaceutical industry. “It’s why there’s a ‘c’ in cGMP. And cGDP, cGLP, and cGXP,” Mutschler explained.

When Perrigo began to implement its global continuous improvement culture, it started by introducing the concepts to top management. “But driving the culture means engraining it in the workforce,” said Mutschler. “It can’t just be top management. It has to be throughout the organization via training and facilitation.”

One way Perrigo did this was by hiring a number of automotive engineers. “They brought a lot of continuous improvement knowledge and applications,” Mutschler said, “and Perrigo took advantage of that. It was very beneficial to apply their knowledge and background.”

The company also established a continuous improvement leader network, and created a global lean sigma network to provide sharing and networking opportunities. “There’s probably someone in the company who’s faced the problem you’re facing,” Mutschler added.

Perrigo also designates continuous improvement “champions”—stakeholders, site leaders, and people who have led the continuous improvement network in the past—and a continuous improvement steering team comprised of executives to provide high-level guidance, governance, and resources.

One of the company’s key techniques is MDI, Mutschler said: “Manage for Daily Improvement.” Others include key behavioral indicators such as Gemba walks.

“Think about what you’re doing if you already have a continuous improvement program,” Mutschler said. “Does it align with your overall business and organizational goals?”

Richard Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality, CDER, FDA, delivered “The Importance of Quality Assurance throughout the Lifecycle,” the second presentation in the session.

“Improving quality performance is important for business reasons,” he began, “but most it’s most important for the patient.” To underscore the point, Friedman presented a partial list of complaints filed with the FDA, including seizure drug capsules that were empty or only partially filled, nonsterile vials, contaminated eye drops, and empty rescue inhalers.

Companies must determine source of failure to minimize hazardous variations, he continued:  methods, machines, materials, measuring systems, environment, and/or people. Whatever the source, he said, “you need support from top management to put the right people at the table to determine root cause.”

“What is a state of control?” he asked. “It starts with process robustness.” This drives sound life cycle decision making, vigilantly monitors processes and product through management oversight.

Risk management is another important part of any quality system oversight. “Do you connect the dots in daily manufacturing? In your supply chain?” he asked the audience. Daily risk management decisions determine reliability of quality and supply. “Drug manufacturers are responsible for implementing dependable daily operations that assure consistent drug quality. Management daily decisions ultimately determine the quality.”

Manufacturers must also be sure they supervise suppliers, CMOs, or vendors, Friedman said. Ongoing supply chain oversight means selection, qualification, monitoring, and risk review. Infrastructure modernization is another factor. “How reliable is the facility and process, whether in house or CMO?

“How do you know if your pharmaceutical quality system is a healthy one?” he asked. “Prevention, correction, and mediation.”

Brian Severson, Water Systems Engineer for Sage Products, finished the session with “The Effects of Critical Utilities on Product Quality.”

Critical utilities are purified or clean utilities used in the manufacture of APIs and final pharmaceutical products, in this case water, steam, and process gases.

Water’s most critical attribute in pharmaceutical manufacturing is an absence of microbial growth, which can proliferate if it becomes part of a drug product. Endotoxins released from gram/negative bacteria can be fatal if ingested or injected.

Severson used an example from industry in which a company had a microbial issue, but couldn’t determine its source. After some investigation, they discovered that a faulty water tank vent filter pulled in microbes as the water cooled. “Simple things can end up being huge problems,” he said.

Steam systems are typically designed to maintain pressure and remove moisture. Noncondensable gases act as insulators and could limit sterilization on portions of the sterilizer load. Contaminants in clean steam for sterilization can also condense on the product.

Process gas issues can be caused by impurity, hydrocarbon levels, moisture content, particulates, or microbial contamination.

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By:  Anna Maria di Giorgio
Editor in Chief, Pharmaceutical Engineering^® Magazine

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