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Track and Trace: A Step-by-Step Guide to Implementing An Effective Program

In compliance, pharmaceutical, regulations by Alicia CheungLeave a Comment

Although the universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply chain integrity to the public. While several states are actively pursuing similar legislation, California’s pending requirements are the most demanding since they track product to the smallest saleable unit level. Enforcement of the ePedigree legislation, combined with the accelerated pace of regulatory involvement worldwide in serialization and track-and-trace means that it is now vital for the industry to accelerate its efforts to put compliance measures in place.

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Serialization: Optimizing Planning and Implementation

In pharmaceutical, Serialization, supply chain by Alicia CheungLeave a Comment

Increased globalization in the supply chain for prescription drugs has also increased the distribution of counterfeit drugs. To combat this problem in the U.S., the FDA has outlined requirements to make every unit of saleable prescription drug products traceable. Meeting the requirements for these regulations requires a long-term strategy and preparation. Recro Gainesville, understanding the changing manufacturing landscape, began this process years in advance. Product serialization enables manufacturers and distributors to protect consumers from potentially harmful counterfeit and stolen drug products by improving supply chain tracking, visibility and management.

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The Serialization Challenge

In biomanufacturing, biotechnology, capacity management, Continuous Improvement, Life sciences, manufacturing, pharmaceutical, Serialization by GenerisLeave a Comment

Successful serialization strategies require a global approach and considerations regarding installation and aggregation capabilities, traceability optimization and adherence to varying regional regulations. In order to better understand the serialization challenges and opportunities that pharmaceutical companies face, we sat down with the specialists from Clarkston Consulting to gather their insights. The eBook explores and explains: The Current Regulatory Landscape The Serialization Challenge Best Practices in Serialization Operationalizing a Serialization Program Check out the eBook below! eBook, The Serialization Challenge To hear insights on Manufacturing Excellence, CMO Strategies, Capacity Management, Quality and Compliance, join Clarkston Consulting at the American Biomanufacturing Summit taking place in San Diego next week!    

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eBook: Q&A with Brandon Varnau, Vice President and Head of Operations Quality, Sanofi Specialty Care

In biomanufacturing, biotechnology, cGMP, Continuous Improvement, facilities, Life sciences, manufacturing, pharmaceutical, Qbd, QMS, Quality by design by GenerisLeave a Comment

Our next eBook features industry insights and forecasts from Brandon Varnau, Vice President and Head of Operations Quality at Sanofi Speciality Care, one of the key speakers at the American Biomanufacturing Summit 2016. We asked Brandon: How biomanufacturing in the U.S. differs from international operations? What are the biggest challenges biomanufacturers currently face? How can these challenges be overcome? What is the biggest opportunity in biomanufacturing? What do you foresee as the ‘next big trend’ to influence biomanufacturing? What major changes to you forecast the industry undergoing over the next 5-10 years? eBook Q&A with Brandon Varnau Brandon joins the speaker line up in San Diego this May to discuss strategies to Create a Quality Compliance Culture Within Biomanufacturing Facilities: Aligning manufacturing and quality objectives to ensure compliance Developing clear compliance expectations for all staff Empowering staff to proactively engage in a culture of compliance Examining various channels and knowledge sharing platforms to communicate compliance practices Find out more about the sessions, case studies and key themes to be addressed at the American Biomanufacturing Summit 2016!

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What to expect from the American Biomanufacturing Summit

In biomanufacturing, biotechnology, cGMP, Life sciences, manufacturing, pharmaceutical by GenerisLeave a Comment

We were thrilled that Robert Sparadoski, Associate Vice President, Quality Assurance at Ferring Pharmaceuticals could join us as a Chair at the American Biomanufacturing Summit 2015.  We caught up with Robert to gather his opinions of the event as a whole. The American Biomanufacturing Summit is returning to San Diego in May 2016. Find out more about the 2016 Summit!

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2016 Life Sciences Outlook

In biomanufacturing, biotechnology, Life sciences, manufacturing, pharmaceutical by GenerisLeave a Comment

There are many changes on the horizon for the life sciences industry. To help pharmaceutical manufacturers navigate the changes ahead Clarkston Consulting has generated the report below to highlight some of the trends and changes that will have the greatest impact on the industry at large. Clarkston Consulting is a leading management, operations & implementation consultancy firm that specializes in the life sciences industry. The report outlines the current state of the industry by looking at the regulatory environment, changes brought on by mergers, acquisitions, and divestitures, serialization challenges and the state of high value biologics, specialty and orphan drugs.  The whitepaper then examines factors that will have the greatest impact on the industry in the years to come and provides insights on how the industry will be able to successfully respond. Explore strategies to overcome the challenges and take advantage of the opportunities in internal manufacturing, external manufacturing, operational excellence, quality management and compliance at the American Biomanufacturing Summit 2016!

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Addressing the Challenges in Biomanufacturing

In biomanufacturing, biotechnology, capacity management, cGMP, innovation, Life sciences, manufacturing, pharmaceutical, production efficiency by GenerisLeave a Comment

The life sciences industry is evolving on a global scale. Shifting market demands, healthcare reforms and more stringent regulations are presenting new challenges to the industry at large. “It is particularly challenging to manage operations globally when dealing with vastly different regulatory review periods for new drug applications as well as making any significant changes to existing dossiers.” explains Ryan Cox, Director, Bulk Manufacturing at CSL Behring. Increased pressure to reduce the cost of healthcare in the US is pushing manufacturers to streamline processes while finding new ways to produce “bio-better” drugs that have a vastly improved pharmacological profile. To remain competitive “biomanufacturers must continue to focus on innovation in terms of making improvements to existing products” explains Ryan. As a result “the industry will need to become much more flexible and “lean” over the next 5-10 years.” Taking a holistic approach to the challenges and opportunities that biomanufacturers face, Generis’ American Biomanufacturing Summit 2016 will present attendees with first-hand case studies, strategies and best practices to advance manufacturing excellence, drive innovation and develop the necessary leadership strategies to ensure long-term success. Produced with the thoughtful input of some of the world’s leading organizations, this senior level program is designed to provide biomanufacturing executives with current trends and strategic insights on internal manufacturing, external manufacturing, operational excellence, quality management and compliance. Annually attracting 150 senior level delegates from across North America, this years program will provide delegates with strategies and insights to …

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eBook: The Opportunities & Challenges in Biomanufacturing

In biomanufacturing, Life sciences, manufacturing by GenerisLeave a Comment

With the American Biomanufacturing Summit 2016 only 9 weeks away, we took some time to sit down with Ryan Cox, Director, Bulk Manufacturing, CSL Behring to gather his thoughts on the challenges and opportunities in biomanufacturing. Check out the eBook below! eBook – Q&A with Ryan Cox To hear more from Ryan, join the discussion at the American Biomanufacturing Summit 2016 taking place on May 10 – 11, 2016 in San Diego.

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