2018 Quality Manufacturing Conference Recorded Sessions

A Global View of Quality

Education Level: Advance

Leaders from industry and regulatory authorities from both sides of the Atlantic share their diverse perspectives on maintaining and improving drug quality in an increasingly globalized world.

Speakers

  • Mark Birse, Deputy Director, Inspection, Enforcement and Standards, Head of Inspectorate, MHRA
  • Giuseppe Randazzo, Acting Office Director, DHHS/FDA/CDER/OPQ/ONDP; Office Director, OPRO
  • John Groskoph, Executive Director, Global CMC, Pfizer Inc.

International Regulatory Convergence

Education Level: Advanced

This session will further explore the Global Regulatory Harmonization presented by Mark Birse in the morning plenary session. Challenges arise for both industry and health authorities as the manufacturing model has shifted from local product manufacturing to manufacturing sites supplying product globally. This session will address some of the challenges for both industry and regulatory authorities related to GMP for global supply, updates on recent efforts to address these challenges, and explore future possibilities.

Speakers

  • Barbara Allen, PhD, Senior Director, Global Quality Systems, Eli Lilly Kinsale Ltd
  • Brian Hasselbalch, Deputy Director of the Office of Pharmaceutical Quality (OPQ), Office of Policy for Pharmaceutical Quality (OPPQ)
  • Obinna Ugwu-Oju, Branch Chief, DHHS/FDA/CDER/CDER/OPQ/OS/DQIRAM/DIB

Patient Centric Specifications

Education Level: Advanced

Currently, it is usual and customary to set drug substance/ drug product (DS/DP) specifications based on the variability observed in limited clinical batches without consideration of the actual impact on the patient (safety and efficacy). This practice could unintentionally reward poor manufacturing process with relatively wider specifications compared to good manufacturing and control that could be penalized to have tighter specifications. In addition, this approach could unnecessarily reject batches that would have met patient’s needs for safe and effective medicine. Hence, it may contribute to drug shortages and drive higher medicine cost. The objective of this plenary session is to discuss the recent progress made by the regulatory agency and industries. The opportunity, challenges and future directions for patient centric specification (PCS) will also be discussed with drug substance and drug product impurity specification as an embodiment. Regulatory and industry speakers will give presentations on this topic followed by a panel discussion.

Speakers

  • Lawrence Yu, PhD, Deputy Director, DHHS/FDA/CDER/OPQ
  • Joel Bercu, PhD, Director, Nonclinical Safety and Pathobiology, Gilead Sciences, Inc.
  • Ann Subashi, Director, Global CMC, Pfizer, Inc.

Challenges of API Starting Materials

Education Level: Advanced

This session will address current issues in today’s global manufacturing environment related to selection and justification of API Starting Materials. A major challenge for industry is selecting API Starting Materials that will be accepted by multiple Regulatory Authorities. The General Principles and examples included in ICH Q11 (published in 2012) did not achieve the hoped-for international harmonization on selection of API Starting Materials. One of the challenges is establishing appropriate controls for the manufacture of the API Starting Material. ICH Q7 describes GMP beginning with the introduction of the API Starting Material through the final API, but it does not describe controls for the manufacture of the API Starting Material.

Speakers

  • Betsy Fritschel, Director Quality and Compliance, Johnson & Johnson
  • Charles Jewell, Acting Branch Chief, DHHS/FDA/CDER/OPQ/ONDP/DNDAPI/NDBI
  • Francois (Swa) Vandeweyer, PE, Director Compliance EMEA/AP, Janssen Pharmaceutica

Lifecycle Management

Education Level: Advanced

Current approaches to pharmaceutical lifecycle management for products that are marketed worldwide are unwieldy, with varied application requirements and approval timelines. The complexity of the resulting supply chains can lead to stock outs and shortages to the detriment of public health. This session will discuss current challenges related to post approval lifecycle management and the potential to alleviate some of these issues through the International Council on Harmonization (ICH) process. ICH Q12, which was recently released to public consultation, contains harmonized tools to reduce post approval regulatory submissions and/or their reporting category. An introduction to ICH Q12 will be provided along with examples of potential use for biologic products.

Speakers

  • Robert Iser, Vice President, Regulatory Consulting Services, PAREXEL International, former FDA Representative on Q12
  • Shannon Holmes, PhD, Associate Director, Regulatory Affairs CMC, Biogen

Lifecycle Process Validation - The Ongoing Quest for Process Excellence

Education Level: Advanced

Historically, Process Validation (PV) was often seen as a checkbox activity regulated to be conducted prior to commercialization. While many companies developed products with rigor, Validation was often perceived as a onetime event without statistical basis or links to the control strategy. Prior to 2011few pharmaceutical companies evaluated processes performance on a frequency greater than annual. With the global introduction of a lifecycle approach (e.g. by FDA, EMA, PICS, ASEA, etc.) to PV, the pharmaceutical industry began applying greater scrutiny to all stages of the product lifecycle as well as leveraging data and statistics for enhanced detection and awareness of process performance. Companies which have implemented a lifecycle approach to PV have reported both enhanced product quality as well as optimized business outcomes (e.g. yield increases, cycle time reductions, and deviation/cost of good improvements, etc.). However, there are areas which may still benefit from a deeper evaluation. This session will focus on areas of continued opportunity and demonstrate how even further process enhancements can be achieved as we attain holistic process excellence. Areas to be discussed include:

  • The statistics pendulum - what’s best for the patient? There is no doubt that the increase in data-based evidence and statistical evaluation that has resulted from implementation of recent validation guidance can have significant benefit to both patient and business. However, when the statistics pendulum swings too far, there are potential negative consequences. Can the right balance be achieved and justified? What obstacles (both statistical and organizational) need to be overcome and prepared for?
  • Linking control strategy and lifecycle process validation. Going from a “release strategy” to a true control strategy that proactively leverages science and risk to define actions for raw materials/components and process awareness through the lifecycle PV strategy.
  • “Data sinks” - areas of continued difficulty obtaining lifecycle process validation data performance awareness and how this can be done efficiently and optimally.

Speakers

  • Tara Scherder, Partner SynoloStats, LLC
  • Monica Hueg, PhD, Global Technology Partner, GMP and Compliance, NNE
  • Amanda Scruggs, Manager, Process Validation and Quality Engineer, Catalent
  • Francis Godwin, PhD, Division Director, FDA/CDER/OC/OMQ/DDQII

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