Introduction & Quality Culture

ICH Q10 is the first globally applicable guideline that clearly describes the role and responsibilities of senior management in terms of developing, communicating, leading, and continually improving the Pharmaceutical Quality System (PQS). The guideline extends significantly outside the basic GMPs described in the regulations and how the PQS needs to be part of running the pharmaceutical operations business. During this recording one of the authors of ICH Q10 describes why and how the guideline was established and FDA provides thoughts as to how the PQS can be successful.

Neil Wilkinson, Senior Partner, NSF-DBA
Steven Lynn, Office Director, OMPQ, CDER, FDA

Actively Using the Quality System to Drive Improvements

Leading edge companies are using the PQS to comply with the GMPs and drive additional improvements company-wide.  Increasingly, companies understand that implementation of the PQS, including principles outlined in ICHQ10, provides an opportunity to change towards more proactive than reactive activities.  The quality benefits of these improvements are leading to more predictable operations and supply reliability at companies. Speakers discuss modern quality system expectations and how this mindset not only improves compliance but reduces business risk.

Richard Friedman, Associate Director, OMPQ, CDER, FDA
Jennifer Magnani, Associate Director, Global Quality, Systems and Processes, Roche
Anders Vinther, PhD, Vice President, Quality Biologics Operating Unit, Global Quality, Roche

The Partnership between Operations & Quality - The Foundation for a Healthy Quality System

Only when Operations and Quality jointly see themselves as accountable for the quality of systems and products can one consider quality being integral to running the business. Practical examples are given of how strategy and goals should be developed and owned together, how the quality system management review can be used to improving effectiveness and efficiency of running the business if one is monitoring, tracking and trending the right metrics. The session discusses specific examples of where senior management should lead the PQS and how this can be done successfully.

Anders Vinther, PhD, Vice President, Quality Biologics Operating Unit, Global Quality, Roche
James Miller, Vice President and Head, Global Biologics Drug Substance Manufacturing, Genentech, Inc.
Jennifer Grealy, Vice President, Manufacturing & Supplier Quality Assessments, Pfizer, Inc.

Management Responsibility Assure the Effectiveness of Operations and Systems

The tangible impact that a pharmaceutical industry manager has on operational dependability and drug quality is difficult to overstate.  Managers are required to make many daily quality system decisions regarding processes, materials, people, machinery, procedures, and facilities that determine whether product quality is assured throughout the lifecycle.  They are responsible for reviewing the ongoing suitability and effectiveness of the Quality System, and the daily operations conducted within it.  Part of this review includes assessing whether staff is properly trained.   Education programs to develop and maintain staff competencies should be a key organizational focus.  A case study is presented illustrating a successful certification program.   

At times, investigation does not uncover the root cause(s) of deviations or failures in operations. These problems can be costly and may be caused, at least in part, by larger underlying systemic deficiencies. Such problems often recur and lead to additional product and financial losses. These issues typically receive significant scrutiny in a regulatory inspection, and can be the subject major FDA 483 citations. Effective management review, including providing oversight into whether your site is “getting to root causes” on both process and system levels, is emphasized.  Other key elements of a well-managed pharmaceutical quality system that avoids major crises are highlighted.

Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc
Jennifer Magnani, Associate Director, Global Quality Systems and Processes, Roche

Quality System Value

Historically, the Pharmaceutical industry paid less attention than other industry sectors to cost efficiency, or continual improvement of processes and systems. For many years a culture of endeavouring to simply pass regulatory authority inspections was too often the norm for defining ‘Quality.’ The true value of Pharmaceutical Quality Systems and Continual Improvement was not realized, and the Cost of (poor) Quality was not measured.

In today’s economic climate, with a rapidly changing industry, Pharmaceutical companies must seek to ensure that a Pharmaceutical Quality System is value-adding, drives the right quality-focused behaviours, is aligned with improvement initiatives, and therefore protects the patient.

Swroop Sahota, PhD, Vice President, Quality Operations, Catalent Pharma Solutions, Inc.
Gerry Migliaccio, Consultant, Migliaccio Consulting, LLC
Ronald Branning, Senior Vice President, Global Product Quality, Genzyme Corporation

Regulatory Expectations of a Pharmaceutical Executive

There has been a significant increase in PQS related GMP deficiency observations written by FDA and international Health Authorities over the past few years. These observations are often addressed to senior management of the company and have been the subject of many notable warning letters.   The emphasis on senior management’s responsibility to actively implement an effective PQS have increased over the last decade, including paying close attention to promptly address quality risks that emerge throughout the lifecycle.  This includes monitoring process stability and raw material quality, as well as external supplier relationships. Industry speakers discuss how quality risk review and process improvement tools are being used by executive management to promote and support consistent product quality.

Sharon Timmis, Vice President, Operational Excellence, Pfizer, Inc.
Anders Vinther, PhD, Vice President, Quality Biologics Operating Unit, Global Quality, Roche

Contact

Jason E. Brown
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org