Certainly, the covid pandemic was an historic moment when the Pharmaceutical industry secured a preeminent place in global headlines. Disruption, restructuring, and transformation continue to be the foundations of the industry’s future. Acceleration in the way vaccines are developed and delivered, increasing digitalization of manufacturing systems, AI, precision medicines, new cures, new demographic trends having access to medicine, and countless other issues are both risks and opportunities. While change is nothing new to an industry driven by R&D, change of this magnitude is complex to absorb within a highly regulated landscape, and the need for structured analytical processes has never been greater.
Kepner-Tregoe works with pharmaceutical companies worldwide to improve transformation agility, troubleshooting capabilities, and compliance systems within all relevant ecosystems. We work with organizations to improve the speed and quality of investigations as well as corrective and preventive measure implementation. Our approach to documented root cause analysis is globally recognized for improving the precision and speed of issue resolution, the CAPA process, and the regulatory compliant documentation of results. Our consulting and capability development programs build confidence in critical thinking skills which in turn translate into a strategic competitive advantage for our clients.
The Kepner-Tregoe methodologies utilize analytical data effectively in order to solve problems and make decisions quickly—and bring transparency to the process. The institutional adoption of our structured processes to call critical functions within client organizations brings sustainable and measurable results. Structured, advanced critical thinking approaches to problem solving and decision making are used and applied across help desks, in logistics and finance functions, and in the executive suites of our pharmaceutical clients.
To learn more about Kepner-Tregoe consulting and training solutions for the Pharmaceutical industry, contact Kepner-Tregoe.
Novartis was developing a new process that in terms of chemistry and equipment was among the most complex ever introduced at one of their manufacturing sites. Added to this was a crushing schedule. It takes several weeks to produce the API used in this drug. When the first batch was completed, the quality was to spec but the quantity was below target yield. The yield problem had to be fixed quickly in order to ensure supply to links further up the chain.
increased sales
Sharing a strong commitment to resolving the yield problem, the team followed the KT's ATS process using data from a variety of sources including manual and electronic batch records and trends, development reports, and production shift logs. The problem was solved, and “fixes” were made. When the first fixed batch was completed several weeks later, it met standard yield. Validation was completed in record time. Novartis beat the competition to market, increased market share, and sales boomed, increasing 20%.
Gerresheimer manufactures specialty glass and plastic products that support the highly regulated pharmaceutical and healthcare industries. Issues arose as the result of a material adjustment - a component made of a soft plastic material had to be changed to a comparable material when the existing one was no longer available. Testing required that a significant amount of product had to be quarantined, because product made with the new material did not meet the specification.
saved
The application of KT process yielded significant results beyond the hundreds of thousands of euros saved when the quarantined batches were released and shipped to the customer. Most importantly, product safety was ensured. The use of KT analysis and the confirmed root cause helped Gerresheimer to eliminate any risk to end-use customers and avoided the potential for recalls of product already on the market.
The site managers at a global biopharmaceutical company explored opportunities to reduce the number of investigations as well as the number of days required to close their investigations. The plant did not have a standard, systematic approach to finding the root cause of manufacturing deviations.
reduction in required investigations
closings dropped to this level, compared with the previous year
The work plan to improve the investigation process and incorporate KT as the investigation methodology was completely developed and implemented in less than six months.
It is no longer acceptable to respond to audits and product recalls with CAPAs that only address short term concerns. It’s now all about aligning CAPAs and Continuous Improvement processes.
Customer complaints can be a significant source of information to control costs and actually enhance customer satisfaction. Using case studies and examples, the author demonstrates how a systematic approach to customer service can improve business results.
When human error is to blame, corrective actions often involve addressing the system itself—its balance of consequences, feedback mechanisms, targets and objectives. Consider five factors that influence human error and offer opportunities for improvement.
Controlling process change can be improved, KT methods support three key areas of process validation: planning, installation and qualification
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