Application-Related Inspections
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Application-Related Inspections
U.S. Food and Drug Administration, FDA, Center for Tobacco Products, CTP, Tobacco Products, Premarket Tobacco Product Applications, PMTA, Modified Risk Tobacco Product Applications, MRTP, Inspections, Manufacturing Sites, Establishment Sites
U.S., Food, and, Drug, Administration;, FDA;, Center, for, Tobacco, Products;, CTP;, Tobacco, Products;, Premarket, Tobacco, Product, Applications;, PMTA;, Modified, Risk, Tobacco, Product, Applications;, MRTP;, Inspections;, Manufacturing, Sites;, Establishment, Sites
Session2-AppRelatedInsp-Burger
Deemed Tobacco Product Applications - A Public Meeting - 10/28/2019 | FDA
Extracted Text
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 PRODUCTS