PhRMA Perspective on FDA Final Report FDA Advisory Committee on Pharmaceutical Sciences October 20, 2004 G.P. Migliaccio, Pfizer Inc.

Slides:



Advertisements
Similar presentations
Project Quality Plans Gillian Sandilands Director of Quality
Advertisements

Roadmap for Sourcing Decision Review Board (DRB)
1 Implementation of Quality by Design (QbD): Status, Challenges and Next Steps Moheb M. Nasr, Ph.D. Office of New Drug Quality Assessment (ONDQA), OPS,
VALIDATION What is the new guidance?. What is a Compliance Policy Guide? Explain FDA policy on regulatory issues CGMP regulations and application commitments.
Integrating CMC Review & Inspection Industry Recommendations Joe Anisko April 24, 2003.
1 Proposed Rule to Protect Food Against Intentional Adulteration
What’s New in the FDA’s Pharmaceutical Inspectorate and Risk Based Systems Inspection Rick Perlman Chair Food, Drug, and Cosmetic Division ASQ.
Presentation By: Chris Wade, P Eng. Finally … a best practice for selecting an engineering firm.
TEMPUS ME-TEMPUS-JPHES
FSMA: Where We’ve Been and Where We’re Going Supplemental Notices of Proposed Rulemaking Public Meeting November 13, 2014 Roberta F. Wagner, B.S., M.S.
Quality System Model ICH Q10
Building a Continuous Improvement Culture BackgroundBackground The Client is a global innovator, manufacturer and distributor of Applied Thermal equipment.
Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science July 20-21, 2004 Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical.
Pilot Risk-Ranking Model to Prioritize Manufacturing Sites for GMP Inspections Advisory Committee for Pharmaceutical Science Manufacturing Subcommittee.
Proposed Rule to Protect Food Against Intentional Adulteration 1.
ONDQA Perspective on Post Approval Changes Eric P. Duffy, PhD Director, Division of Post-Market Evaluation, ONDQA, CDER, FDA Public Meeting: Supplements.
1 Revisions to 21 CFR Supplements and Other Changes to an Approved Application PhRMA Perspective FDA Public Meeting – 7 Feb 2007.
Radiological Devices Advisory Committee Meeting November 18, 2009 John A. DeLucia iCAD, Inc.
FDA’s Perspective Continued - Where We Are ?. GMP Task Groups.
COSO Framework Update IIA Columbus Chapter May 17, 2013
Internal Auditing and Outsourcing
Executive summary prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1 ICH Q9 QUALITY RISK MANAGEMENT.
ISO 9001:2015 Revision overview - General users
EHS Management System Elements
Regulatory Update Ellen Leinfuss SVP, Life Sciences.
Achieving and Demonstrating “Quality-by-Design” with Respect to Drug Release/dissolution Performance for Conventional or Immediate Release Solid Oral Dosage.
OECD Guidelines on Insurer Governance
Developing a partner reward strategy – to build competitive advantage Peter Scott Peter Scott Consulting
ISO 9000 and Public Awareness and Information Session 22 February 2006 Owen Glave, MBA-TQM.
Industry Perspective on Challenges for Product Developers - Drugs Christine Allison, M.S., RAC Associate Regulatory Consultant, Global Regulatory Affairs.
1 Supplements and Other Changes to an Approved Application By: Richard J. Stec Jr., Ph.D. February 7, 2007.
Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science, CDER, FDA ACPS Subcommittee on Manufacturing Science: Identification and Prioritization.
FDA Science BoardNov 5, CDER Risk-based Site Selection Model: An FDA Risk Management Tool Presentation to FDA Science Board November 5, 2004 by Kara.
© 2011 Underwriters Laboratories Inc. All rights reserved. This document may not be reproduced or distributed without authorization. ASSET Safety Management.
PwC 21 CFR Part 11 – A Risk Management Perspective Patrick D. Roche 07 March 2003, Washington D.C.
FDA’s Perspective on the “Pharmaceutical cGMPs for the 21st Century” Initiative David J. Horowitz, Esq. Director, CDER/FDA, Office of Compliance Advisory.
ISO 9001:2008 to ISO 9001:2015 Summary of Changes
April 2008 Global Developments in Corporate Reporting Charles Tilley Chartered Institute of Management Accountants Chief Executive Global Developments.
1 Cross Labeling Combination Products Bradley Merrill Thompson, MBA, JD, RAC Epstein Becker & Green PC.
1 Upgrading of the Framework Requirements for the Development of VQS in Bulgaria Dr Cloud Bai-Yun May 2006, Sofia EuropeAid/120164/D/SV/BG.
Quality by Design & Question-Based Review: Observations by the Generic Pharmaceutical Industry Advisory Committee for Pharmaceutical Science October 5,
Risk-Based CMC Review - OGD Perspective Gary J. Buehler, R.Ph. Director Office of Generic Drugs July 21, 2004 Advisory Committee for Pharmaceutical Science.
Molecule-to-Market-Place Quality
COMPARABILITY PROTOCOLUPDATE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE Manufacturing Subcommittee July 20-21, 2004 Stephen Moore, Ph.D. Chemistry Team.
10:00 A.M. – Noon 7 June 2004 ICH Quality Plenary Meeting.
Agenda for Session Compliance in Clinical Research
An Update of COSO’s Internal Control–Integrated Framework
Part 11 Public Meeting PEERS Questions & Responses The opinions expressed here belong to PEERS members and not the corporate entities with which they are.
FDA Regulatory and Compliance Symposium
2015 Pipeline Safety Trust Conference November 20 th, 2015 | New Orleans, LA API RP 1175 Pipeline Leak Detection Program Management – New RP Highlights.
Progress in FDA’s Drug Product Quality Initiative Janet Woodcock, M.D. November 13, 2003.
Unit-5 Introduction to IS/ISO 9004:2000 – quality management systems – guidelines for performance improvements. Presented by N.Vigneshwari.
Research in the Office of Vaccines Research and Review: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation and Research.
Research in the Office of Cellular, Tissue and Gene Therapies: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation.
ICH Quality Topics Update
Virginia Office of Public-Private Partnerships (VAP3) Adopted Public-Private Transportation Act (PPTA) enabling legislation in 1995 Public-Private Education.
CDER / Office of Compliance ACPS October 5, 2006 Joseph C. Famulare Acting Deputy Director Office of Compliance CDER / FDA.
MDIC/Xavier University Device Product Quality Metrics December 8, 2015.
FDA’s Advisory Committee for Pharmaceutical Science The Subcommittee on Process Analytical Technologies (PAT): Closing Remarks Ajaz S. Hussain, Ph.D. Deputy.
Drug Quality Regulations for the 21 st Century PhRMA Perspective Manufacturing Subcommittee Meeting – May 21, 2003 Gerry Migliaccio Pfizer Inc.
Use of Risk-based Approach for Regulating CMC Changes to Approved Applications FDA Public Meeting February 7, 2007.
Examining Drug Quality Regulation Douglas C. Throckmorton, MD Deputy Director Center for Drug Evaluation and Research Public Meeting on 21 CFR February,
ICAJ/PAB - Improving Compliance with International Standards on Auditing Planning an audit of financial statements 19 July 2014.
1 From Regulatory Intelligence to Compliance Debbie Henderson Head, Global Regulatory Policy EU Ring May 13, 2014.
Guidance Development Merton V. Smith, Ph.D., J.D. Director International Programs and Product Standards Center for Veterinary Medicine, FDA.
ดูแลด้วยความรับผิดชอบ
Pharmaceutical Quality in the 21st Century
Quality System.
The Strategic Information Technology Formulation
Implementation of Quality by Design (QbD): Status, Challenges and Next Steps Moheb M. Nasr, Ph.D. Office of New Drug Quality Assessment (ONDQA), OPS, CDER.
Presentation transcript:

PhRMA Perspective on FDA Final Report FDA Advisory Committee on Pharmaceutical Sciences October 20, 2004 G.P. Migliaccio, Pfizer Inc

Discussion Topics Culture Change General Comments on Report Quality Systems Guidance Risk-Based Inspection Model ONDC Risk-Based Quality Assessment System Summary

Three Years of Culture Change An unprecedented period of communication and learning for both FDA and Industry. The culture change has been driven by open communications and a shared vision of the desired state. PAT was the model, much has followed.

Two Years of Culture Change Industry is moving from a fear of data to a passion for process understanding. Science, not blind compliance, is winning the day more often. Innovation is accelerating throughout industry. Interactions during inspections are changing.

General Comments on Final Report This is not the end, it is the beginning! PhRMA applauds the magnitude of what has been accomplished and the rigor in which it was accomplished. FDA and Industry Leadership must continue to work together to ensure that the guidance and position papers are fully understood, modified as appropriate, and implemented. Much remains to be accomplished to realize our shared vision.

Quality Systems Guidance Comprehensive and of great utility. Companies are already using to assess Quality Systems infrastructure. Key outstanding issue is defining the level of process understanding required to achieve flexible continuous improvement. Imperative that these concepts be addressed at global level and the FDA guidance provide a starting point for ICH discussions relative to the proposed Q10.

Quality Systems Guidance FDA and Industry must move away from current “Compliance Systems” to be able to achieve all elements of Quality Systems Guidance.  e.g. Trending of data  Some data generated for compliance purposes can not be trended to gain process understanding.  Current specification system must evolve to allow reporting of meaningful data on CTQs.

Risk-Based Inspection Model Solid step forward to allow FDA to focus on higher risk sites. Elements of the algorithm require further discussion – e.g. volume. PhRMA has serious concerns about transparency.

Risk-Based Inspection Model “Survey results were analyzed and process control and contamination weights were assigned to each product category identified in the expert elicitation survey.” “Individual risk-factor weights and final scoring information, as well as specific information used to generate the weights and scores, are intentionally not provided in this paper. FDA does not intend to publish or disclose such details of a site’s individual score or ranking, in order to effectively enforce the law.”

Risk-Based Inspection Model “FDA’s customer relationship with industry will differ depending on the transactions involved. At one end of the spectrum, industry clearly is a direct customer of FDA’s products or services. For example, when FDA develops guidance documents representing the agency’s current thinking on a particular subject, we provide clarity and understanding to firms that manufacture FDA regulated products. With this information, industry has a better understanding of the agency’s expectations about their products, and this may enable companies to manufacture products more effective or approach regulatory milestones with greater certainty.” From Defining the Customer in a Regulatory Agency, Appendix B

Risk-Based Inspection Model “FDA will now be using a Quality Systems approach to improve the predictability, consistency, integration and overall effectiveness of our entire regulatory operation.” from “Final Report”

Risk-Based Inspection Model If FDA and Industry do not have a mutual understanding of what processes/unit operations are higher risk, how can FDA and Industry appropriately focus their respective resources on high risk areas? Transparency is essential.

ONDC Risk-Based Quality Assessment System Represents a profound change in the organization and review process. PhRMA supports the objective, but much work is required to achieve the end state. Will FDA approach this change with the same level of leadership commitment and reviewer availability as demonstrated with the PAT and GMP initiatives? Will FDA work with industry to ensure that the objectives can be achieved?

ONDC Risk-Based Quality Assessment System ONDC proposal could create expectations that there will be a significant increase in the knowledge provided “up front”.  Companies will provide different information resulting in a greater degree of process understanding, but at NDA submission, the level will be limited.  Process knowledge will be sufficient to establish that a robust process has been developed.  Process understanding is a continuum, and will accelerate post approval.

ONDC Risk-Based Quality Assessment System FDA should work through ICH to establish a global partnership for the risk-based quality assessment system. We should not exacerbate the current differences in assessment systems but work to establish a global assessment approach.

ONDC Risk-Based Quality Assessment System Pre- and Post-Marketing approach requires further evaluation. Process understanding significantly increases during first 1-2 years of marketing and potential for continuous improvement is highest. There is value to having the NDA reviewer also review these continuous improvement changes.

ONDC Risk-Based Quality Assessment System FDA has implied that there will be two assessment systems, one for applications including manufacturing science/process understanding, the other without.  Process understanding is not a “yes” or “no”, it is a continuum.  Every application will have a different level of process understanding.  How will a reviewer determine where any application is in this continuum?

Summary The infrastructure is in place – some modification required. The culture is changing. The desired state is on the horizon.