Deemed Tobacco Product Applications - A Public Meeting - 10/28/2019 | FDA
APPLICATION-RELATED INSPECTIONS Presented by Chad Burger Branch Chief Division of Enforcement and Manufacturing Office of Compliance and Enforcement, CTP, FDA Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy. October 28- 29, 2019 Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS AGENDA · FDA Inspection Authority · Types of Application-Related Inspections · What to Provide in an Application to Prepare for an Inspection · What to Expect Before an Inspection · Inspection Objectives · Initiating an Inspection · Inspection Close-out · Resources 1 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS FDA INSPECTION AUTHORITY Section 704(a) of the FD&C Act: · Factories, warehouses, establishments, vehicles. · All pertinent equipment, finished and unfinished materials, containers, and labeling. Inspections are performed by: · Office of Regulatory Affairs (ORA) · Tobacco Operations Staff · Center for Tobacco Products (CTP) · Representatives from the Office of Compliance & Enforcement (OCE) 2 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS TYPES OF APPLICATION-RELATED INSPECTIONS Manufacturing (Establishment) Inspections: · Establishments associated with the manufacture, testing, or storage of the tobacco product(s) subject of the application(s) submitted to the Agency. · Should be inspection-ready at the time of application submission. Bioresearch Monitoring (BIMO) Inspections: · Sites and entities associated with clinical and nonclinical studies submitted in support of the premarket application(s) submitted to the Agency. Inspections may be performed domestically or internationally. · Form FDA 482, Notice of Inspection will be issued during domestic inspections. 3 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS WHAT TO PROVIDE IN AN APPLICATION TO PREPARE FOR AN INSPECTION Manufacturing Inspections: · A full description of each manufacturing and testing facility: · Address, point of contact, and assigned Firm Establishment Identifier (FEI) number. · A full description of all manufacturing and testing activities, processes, and controls performed at each facility. · A narrative description, accompanied by a list and summary of all standard operating procedures (SOPs). · If available, production schedule(s) for each of the final manufactured products subject to the application(s) for the first four months after the dates of the submission of your application(s). 4 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS WHAT TO PROVIDE IN AN APPLICATION TO PREPARE FOR AN INSPECTION Bioresearch Monitoring: · List of all clinical / nonclinical studies submitted in support of an application. · List of all sites and investigators that conducted the study. · All versions of protocols and amendments that were used in the study. · Line data. · Location of all source data. · List of all contractors who participated in the study. · Full report of all findings. 5 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS WHAT TO PROVIDE IN AN APPLICATION TO PREPARE FOR AN INSPECTION Bioresearch Monitoring: · Documentation of all actions taken to ensure the reliability of the study data and protection of human subjects. · All versions of study materials. · All versions of case report forms. · Individual subject case report forms. 6 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS WHAT TO EXPECT BEFORE AN APPLICATION-RELATED INSPECTION Pre-Inspection Notification: · Manufacturing Inspection(s) · BIMO Inspection(s) Purpose of Pre-announcing: · To notify the applicant/sponsor/investigator what sites are planned for inspection. · To provide information to prepare the appropriate documentation for the inspection. · Note that documents other than what was requested in the inspection pre-announcement may be requested during the inspection. 7 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS INSPECTION OBJECTIVES · Review processes and procedures. · Observe and evaluate operations (manufacturing only). · Document and collect information. · Identify violations. · Communicate potential violations to firm management. · Document any proposed corrective action plans. 8 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS INITIATING AN INSPECTION · Meet with most responsible person on site. · Present FDA credentials. · Issue Form FDA 482, Notice of Inspection. · domestic inspections only. 9 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS WHAT IS COVERED DURING AN APPLICATION-RELATED INSPECTION Manufacturer Inspection · Administrative information · Facility walk-through · Observe the manufacturing process · Review of packaging, labeling, and advertising BIMO Inspection · Human subject protection · Protocol compliance · Data audit 10 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS INSPECTION CLOSE-OUT What happens: · Close-Out discussion. · Discuss observations with management. · Issue Form FDA 483, if necessary. · Solicit firm's responses to observations. 11 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS INSPECTIONS FINAL REPORT Establishment Inspection Report (EIR): · Describes the information discussed and collected during the inspection. Field Management Directive 145: · Copy of EIR to inspected entity. · Sent to most responsible individual identified during the inspection after decision has been made on the application(s). 12 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTS FDA RESOURCES AND CONTACT INFORMATION CTP Website: · http://www.fda.gov/TobaccoProducts/default.htm CTP Webinars: · https://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm220111.htm For General Inquiries, contact via email or phone: · AskCTP@fda.hhs.gov · 1-877-CTP-1373 Sign up for updates: · https://www.fda.gov/tobacco-products/ctp-newsroom/sign-email-updates-ctp Investigations Operations Manual (IOM): · https://www.fda.gov/iceci/inspections/iom/default.htm Regulations: Good Clinical Practice and Clinical Trials: · https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinicaltrials Reporting Complaints Related to FDA-Regulated Clinical Trials: · https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/reporting-complaints-related-fda-regulatedclinical-trials 13 October 28-29, 2019 | Deemed Tobacco Product Applications: A Public Meeting CENTER FOR TOBACCO PRODUCTSU.S. Food and Drug Administration, Center for Tobacco Products Adobe PDF Library 19.21.79