Regulatory Expectations of Executive Management

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1 Regulatory Expectations of Executive Management Steven Lynn, MS, CMQ/OE Director Office of Manufacturing and Product Quality Office of Compliance CDER/US FDA PDA ICH Q10 Executive Management Workshop PDA ICH Q10 Executive Management Workshop September 12, 2012 (Baltimore, MD)

2 TOPICS Pharmaceutical Quality in the 21 st Century Executive Management Role Must Establish a Culture of Quality Importance of a Robust Pharmaceutical Quality System

3 Pharmaceutical Quality for the 21 st Century 3

4 Pharmaceutical Quality for the 21 st Century Regulatory paradigm shift to: Performance and Management Based Establish performance standards Lifecycle focus Evaluate capability of firm s quality system to consistently meet performance standards, including determining: whether state of control is maintained throughout lifecycle determining how effectively the facility manages risks Allow flexibility for technological advancement and continual improvement

5 Pharmaceutical Quality for the 21 st Century Industrial paradigm shift to: Quality Systems approach, with strong process performance and quality monitoring programs, and a proactive quality culture Engaged Senior Managers who create and reinforce the quality culture, through both policies and actions Scientific risk management throughout lifecycle, with continual improvements made based on knowledge gained

6 ICH Q10 EWG Mission To establish a new tripartite guideline describing a model for an effective quality system needed to establish and maintain a state of control that can ensure the realization of a quality drug product and facilitate continual improvement over the product life cycle.

7 Quality Systems: Global CGMPs and ISO CGMPs Systems, programs, and procedures Process Control (reliable and repeatable processes) Quality unit responsibility and authority Supervisory responsibilities Qualified personnel Flexibility to develop the most suitable operating procedures and implement novel approaches ISO 9000 General guidelines on quality management systems for various industries e.g., ISO ISO 9004, Performance Improvement ISO 9000 framework is very aligned with CGMP 7

8 EXECUTIVE MANAGEMENT ROLE 8

9 FDA Expectations Assure a State of Control Companies are accountable for the quality of the products they produce FDA evaluates the state of control using its quality systems inspection approach (since 2002 for drug facilities) A robust quality system will assure a state of control

10 Senior Management must: FDA Expectations Assure a State of Control Vigilantly oversee quality and support continual improvement Create a proactive quality culture Detect new variables or events that may affect product quality, and respond with appropriate actions Establish mechanisms to ensure science and risk based decisionmaking throughout the lifecycle Assure clear and open communications Within their own companies With the Agency (e.g., the agency should be notified when a problem arises that has potential to adversely impact public health)

11 Commitment to quality Essential from the top down and bottom up Cannot settle on meeting perceived regulator s minimum standard Must meet YOUR standards to reliably produce high quality products What Dr. Woodcock said. proactively identify & promptly correct issues design/qualify robust operations maintain equipment and facilities Implement robust quality systems Significant impacts to the public s health Cost of poor quality $$$$$$ Cost to patients shortages, adverse events, etc. 11

12 Malcolm Baldridge Framework for Organizational Excellence 12

13 Responsibility, Authority, and Organizational Structure Determining the firm's organizational structure, and asking authority and responsibility questions is fundamental to all FDA inspections

14 Responsibility, Authority, and Organizational Structure Report full names and titles of owners, partners, and corporate officers. Who has the duty, power and responsibility, and authority to prevent, detect, and correct violation(s), and how is this demonstrated and/or documented? FDA Investigations Operations Manual (IOM)

15 Responsibility, Authority, and Organizational Structure Report the chain of command; include an organizational chart (create if necessary) Organizational chart includes operations, quality unit and other managers, and reporting relationship to top management. IOM 15

16 Responsibility, Authority, and Organizational Structure Discussion with management (e.g., upon issuance of an FDA 483) at the close of the inspection: After completion of the inspection, meet with the highest ranking management official possible to discuss your findings and observations. Obtain management's intentions regarding correcting objectionable conditions. - FDA Investigations Operations Manual (Section 5.2.7) 16

17 Who is Responsible for Adulterated Products? Under the Federal FD&C Act, a drug is adulterated if it is not manufactured in conformance with CGMP* [21 U.S.C. 351(a)(2)(B)] Top executives of the company, operations managers, and quality managers are examples of individuals who have fundamental roles in preventing these violations Introducing or causing the introduction of an adulterated drug into interstate commerce is a prohibited act. [21 U.S.C. 301] Applies to finished drug products, drug components and all sites under contract to manufacture or supply drugs and drug components. Also applies to private label distributors. Persons or corporations can be held liable (includes prosecution) United States v. Park 421 U.S. 658 (1975) *In addition to CGMP, a drug can also be deemed adulterated under other provisions of the Act (See Section 351) 17

18 CGMP includes Management Oversight of Safety and Quality, including Addressing Risks of Materials and Drug Products SEC ENHANCING THE SAFETY AND QUALITY OF THE DRUG SUPPLY. Section 501 (21 U.S.C. 351) is amended by adding: For purposes of paragraph (a)(2)(b), the term current good manufacturing practice includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. 18

19 IMPORTANCE OF A ROBUST PHARMACEUTICAL QUALITY SYSTEM 19

20 THE ECONOMIST: August 31st 2002 Pharmaceuticals: Trouble in the making For all the glamour of invention, the latest blockbuster medicine, like the hottest new fashion, can unravel if manufacturing falters. Witness the slew of drug makers that have fallen foul of the FDA, their regulator in America.. [GK Raju, 2011 ICH Q10 Conference] 20

21 Thought. Clearly the responsibility for maintaining quality rests squarely with the manufacturers themselves...the widespread and successful adoption of six sigma and related quality management techniques in other manufacturing sectors would imply that reliable, high quality manufacturing is also attainable in the pharmaceutical sector. We must ask ourselves, in an area where the stakes are so high, why is this not being achieved? Dr. Janet Woodcock Commentary in May June 2012 edition of PDA Journal 21

22 Potential Risks from a Product (or Ingredient) Problem Corporate/business Risk Poor Quality Interruption in manufacturing or supply. Disqualification of supplier and need to qualify new supplier. Customer complaints and returned goods. Loss of reputation, profits, market share. Decline in stock value.

23 Potential Risks from a Product (or Ingredient) Problem Patient/consumer Risk Lessened, excessive or inconsistent therapeutic effect. Side effects and transient adverse events. Permanent adverse effects. Loss of confidence in safety and quality of drug(s). Needed drug is unavailable.

24 Benefits of an Effective Quality System Support and Ownership of Quality Goes Beyond the Quality/Compliance Units A Culture of Quality Yields Many Benefits: Enhanced Process Stability Drives Productivity and Performance. Prevention Reduces Compliance Risks and Costs. Best Plants have Fewer Significant Complaints and Investigations and Therefore More Efficient QA Release of Batches. Protection of Brand.

25 Why Comply: Impact on Reputation When I say BP, what do you think? When I say Ford Pinto, what do you think?

26 The Cost of Non Compliance Summary of Results Source: PDA/ISPE Survey

27 Taguchi s Quality Loss Function (QLF) We cannot reduce cost without affecting quality. We can improve quality without increasing cost. We can reduce cost by improving quality. We can reduce cost by reducing variation. When we do so, performance and quality will automatically improve!

28 But wait..failure costs are only 1 part! Inefficient Processes are Costing Massive Amounts of Money Process Variation of product characteristics (even on conforming products) are a big money waster There s s untapped patient safety and financial opportunities just waiting for senior management to take notice! 28

29 Comparative Cost of (Poor) Quality Most Costly 1000x Less $ $ Costly Least 100x Costly 1x Defect found after it s delivered to customer External Failure Cost Defect found at company before being shipped Internal Failure Cost Source: Principles of Quality Costs, 3 rd Edition, Campanella, Pg. 8 No Defect! The Firm s QMS is designed, planned and organized for defect prevention and continual improvement Prevention Cost

30 Investigations: Getting to Root Causes continued A large number of recent manufacturing failures can be traced to failures in the firm s quality management system (QMS). In some cases, the QMS ignored or failed to follow up on customer complaints. In other cases, multiple repeated deviations were treated as separate incidents, rather than an obvious trend. Another reoccurring theme has been investigations to nowhere end with no additional understanding or insight into why the problem may have occurred and thus no hope for prevention. All of these failures suggest a QMS that is insufficiently empowered or resourced to adequately carry out its essential functions. Dr. Janet Woodcock Commentary in May June 2012 edition of PDA Journal

31 Top 5 GMP Regulatory Violations found in 2011 WLs (Domestic and Foreign) Top 5 GMP Regulatory Violations found in 2011 WLs Control of Components, Contriners, Closures, 5.69% GMP Regulatory Violations Production and Process Controls, 9.76% Lab Controls, 8.94% Production and Process Controls, 8.13% Records and Reports, 18.70% Control of Components, Contriners, Closures Production and Process Controls Lab Controls Production and Process Controls Records and Reports 0.00% 5.00% 10.00% 15.00% 20.00% Percentage of Violations out of a Total of 45 WLs 31

32 Reinvest: Process and Quality Improvement Ownership of Quality Must Go Beyond the Quality and Operations. Financial Support Top Management must provide financial support Reinvestment Is needed to maintain stable facilities, processes, and systems Should include planned allocations to upgrade operations, not reacting to crises Quality Dividend Best Plants have fewer significant complaints and investigations, and therefore higher quality and more efficiency (yield, supply timeliness). 32

33 Conclusion An EFFECTIVE, EFFICIENT and ROBUST quality system: 1. Requires leadership that is informed and committed to reinvesting in facilities; 2. Allows manufacturers to achieve consistently high quality drugs; 3. Includes monitoring and adapting your operations cost $$, but it ultimately pays off; 4. Prevents the snowball effect: Little things that are neglected ultimately snowball to crises later. Don't wait until it is too late to readily respond. 5. Planned reinvestment in manufacturing (ex: facilities, equipment, infrasture, people, etc) should be a strategic budgetary priority 6. Quality and Business benefits include consistent high quality and predicable supply: the two basic responsibilities of any manufacturer 7. Helps to Reduce Risk

34 Acknowledgments Rick Friedman, CDER/OC/OMPQ G.K. Raju, Light Pharma

35 Thank You! Steven Lynn, MS, CMQ/OE Office of Manufacturing and Product Quality (OMPQ) m# FDA/CDER/Office of Compliance Hiring: Jobs Listed on

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