American Society for Quality Region 5 Quality Conference Darning the Quality Safety Net CDR Gayle Lawson, Pre-Approval Manager U.S. Food & Drug Administration Philadelphia District October 25, 2017 www.fda.gov

US Food & Drug Administration FDA Mission Statement   FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.   FDA is also responsible for advancing the public health by helping to speed innovations that  make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing  and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

www.fda.gov Office of the Commissioner Office of Foods and Veterinary Medicine Center for Food and Applied Nutrition Center for Veterinary Medicine Office of Global Regulatory Operations and Policy Office of Regulatory Affairs Office of Medical Products and Tobacco Center for Drug Evaluation and Research (CDER) Center for Devices and Radiological Health (CDRH) Center for Biologics Evaluation and Research (CBER) Center for Tobacco Products Office of Operations Office of Policy Planning Legislation and Analysis www.fda.gov

FDA/ORA Structure FDA consists of Centers and Offices, commodity-based located in vicinity of Washington, DC. Center for Drug Evaluation and Research (CDER) Center for Food and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Center for Devices and Radiological Health (CDRH) Center for Biologics Evaluation and Research (CBER) Center for Tobacco Products (CTP) Office of Regulatory Affairs (ORA) personnel and work offices located throughout the US (and globally) to conduct face to face operations with regulated industry including inspections, facilitate recalls, compliance corrections, etc. Mission Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.

Office of Regulatory Affairs Associate Commissioner Office of Pharmaceutical Quality Operations Office of Medical Devices and Radiologic Health Operations Office of Biological Products Operations Office of Bioresearch Monitoring Operations

Office of Regulatory Affairs Program Alignment Regroup of ORA structure/personnel to commodity-based operations from historically geographic district/region operations Vertically-aligned, ORA to Centers Divisions, rather than District Transition period

Pharma

Medical Devices

Bioresearch Monitoring

FDA Authority/Jurisdiction Food Drug & Cosmetic Act Code of Federal Regulations (CFR)   FDASIA: Food Drug Administration Safety and Innovation Act New authorities to address the challenges posed by increasingly global drug supply chain Section 705: Risk-based Inspection Frequency Section 706: Records for Inspection outside of an on-site inspection Section 707: Prohibition against delaying, denying, limiting, refusing inspection Section 710: Exchange of Information (enter agreements with foreign govt) Section 712: Recognition of Foreign Government Inspections DSCSA: Drug Supply Chain Security Act Guidances, FDA current thinking on how to comply with law Contract Manufacturing Arrangements for Drugs: Quality Agreements Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Quality and Problem Management What happens when your quality system fails you? What happens when something slips through the cracks of the quality safety net? How do we go back and mend the threadbare parts of our quality system?

Identify Assemble supplies Obtain instructions Execute-darn it Marvel at your work

Mending the Quality Safety Net

OOS and investigations Rejected batches Regulatory Audit deficiencies 1. Identify Weaknesses OOS and investigations Rejected batches Regulatory Audit deficiencies Enforcement Actions- your own/industry WLs Complaints Packaging Mix-ups Labeling errors Internal audit program www.fda.gov

Problem Management Math Level 1 + Level 1 = Level 2 Level 1 + Level 1 + Level 1 = Level 3 Minor + Minor Major

Understand exact root causes, contributing factors 2. Assemble Resources Understand exact root causes, contributing factors Build cross-functional teams Provide training Improve collaboration, internal & external Obtain expert/additional resources

Change Control – GMP/non-GMP SOPs and other documents 3. Improvement Planning Change Control – GMP/non-GMP SOPs and other documents External Contracts Interdepartment/facility agreements

4. Execute Changes Review and assess project. Qualified persons’ authorization. Quality Unit authorization.

5. Marvel/Celebrate Accomplishments Successful Quality Metrics No supply interruptions No rejected batches Decrease/limit FARs Recalls OOS Investigations Decreased deviation investigations

Don’t let this happen to your quality safety net

Questions & Discussion. Thank you. Questions & Discussion.