Preamble to GMP Kefauver-Harris Amendments

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1 CGMP for Phase 1 Clinical Trials Harvey M. Arbit, PharmD, MBA, RAC, CCRP University of Minnesota Academic Health Center Director, IND/IDE Assistance Program Lead, Regulatory Knowledge and Support Clinical and Translational Science Institute Adjunct Associate Professor College of Pharmacy Disclosure of Relationships and Declarations CNE and CME Accredited SoCRA Programs Disclosure of Relationships and Declaration forms are collected from all planners and speakers. All current employers of all speakers are included in the program agenda and are presented as a part of the individual verbal introductions that include a short biographical sketch for each planner and speaker. Planners and Speakers will have declared and resolved any commercial interests. SoCRA program content addresses regulatory issues and clinical research policies and procedures. No commercial therapies are discussed, no commercial (drug/device/biologic) products are discussed, and no commercial support is involved with SoCRA programs. Planners and Speakers for this program have no undisclosed commercial relationships. Erich Lukas, Executive Director HMA 9/26/ Kefauver-Harris Amendments Manufacturer had to prove safety & efficacy Clinical trials had to include informed consent Regulated advertising of Rx drugs Established GMP Required that all drugs introduced between had to be effective HMA 9/26/09 2 Preamble to GMP Part 211 applies to all types of pharmaceutical production FDA considered proposing additional regulations governing investigational drugs HMA 9/26/09 3 1

2 Overall Purpose of CGMP: Federal Food, Drug, and Cosmetic (FD&C) Act and CGMP Drug is considered adulterated if CGMP is not followed CGMP ensures drug meets safety requirements Identity, strength, purity, and quality characteristics for which it purports are met An extremely important part of CGMP is documentation HMA 9/26/09 4 What CGMP Does for Us Provides for systems that: assure proper design, monitoring, and control of manufacturing processes and facilities. assure the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. prevent instances of contamination, mix-ups, deviations, failures, and errors. assure that drug products meet their quality standards. HMA 9/26/ (a)(2)(B) of the FD&C Act Deemed adulterated if Methods used in, or the facilities or controls used for its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with CGMP To assure it meets the requirements of the Act as to safety To have the identity and strength To meet quality and purity characteristics To purport or is represented to possess HMA 9/26/09 6 2

3 21 CFR 211 CGMP General provisions Organization & personnel Buildings & facilities Equipment Control of components & drug product containers & closures Production & process controls Packaging & labeling control Holding & distribution Laboratory controls Records & reports Returned & salvaged drug products HMA 9/26/09 7 Guidance for Industry: CGMP for Phase 1 Investigational Drugs (July 2008) Applies to the manufacturing of drugs/biologicals used in phase 1 clinical trials Exempt from 21 CFR 211 Applies QC principles to the manufacture of phase 1 investigational drugs Facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects Comply with 501(a)(2)(B) of the FD&C Act HMA 9/26/09 8 Why Doesn t 21 CFR 211 Apply? 21 CFR 211 is intended for commercial drug manufacture, which does not apply for Phase 1 investigational drugs 21 CFR 211 is applicable for Phase 2 and Phase 3 clinical trials Important to initiate good manufacturing practices in phase 1 to make transition to phase 2 CGMP compliant 1991 FDA Guidance titled, Preparation of Investigatory New Drug Product (Human and Animal) still applies to Phase 2 and 3 trials HMA 9/26/09 9 3

4 Some parts of 211 not appropriate for phase 1 clinical trial materials Directed at commercial manufacture Large, repetitive, batch production Validation of manufacturing process Warehousing HMA 9/26/09 10 IND application and CGMP IND informs FDA on steps taken to ensure safety and quality CMC section IND must contain adequate methods, facilities, and controls to manufacture,,p process, and package investigational drugs Allows for standards of identity, strength, quality, and purity as needed for patient safety FDA has option to place study on clinical hold Unreasonable or significant risk IND s information is insufficient to assess risk HMA 9/26/09 11 Statutory CGMP IND regulations 21 CFR 312 CMC information Safety information FDA inspection Clinical hold / terminate IND HMA 9/26/

5 Recommendations in implementing Statutory CGMP controls Personnel QC function Facility & equipment Control of components, and containers & closures Manufacturing & records Laboratory controls Packaging, labeling & distributing Recordkeeping HMA 9/26/09 13 How to Comply with Statutory CGMP In phase 1 studies, quality control (QC) maintains quality and safety standards Development and Adherence to QC: Well defined written SOPs Equipment is adequately controlled Data from production and testing accurately and consistently controlled Records must be sufficient to replicate the manufacturing process HMA 9/26/09 14 Quality Control Functions Examine materials involved in product development to ensure quality standards are met Examine procedures related to testing and production Release or reject each clinical batch based on adequate production records or other relevant information Investigate and initiate corrective action if errors occur during production HMA 9/26/

6 Personnel Training The FDA recommends that all personnel have appropriate, documented education and training Personnel should: Be familiar with CGMP, and how it s implemented Recognize QC functions Have appropriate experience in producing investigational product Understand and follow suggestions from the FDA s guidance document on CGMP for phase 1 HMA 9/26/09 16 Facility and Equipment Facilities should have adequate space, clean environment, and appropriate layout Appropriate lighting, ventilation, heating Appropriate cooling, plumbing, washing and sanitation Appropriate air handling systems Appropriate equipment that will not interact with product and is properly maintained according to SOPs Equipment must be calibrated and checked periodically for accuracy HMA 9/26/09 17 Control of Components Written SOPs detailing control of components used in production of investigational product Control of components before and during product development Review of defined specifications of raw materials, in- process materials, packing and labeling Log book to document: Details of product shipment Product characteristics Storage conditions Investigational batch number HMA 9/26/

7 Laboratory Controls Testing Analytical tests should be scientifically sound and reproducible Written procedures for testing methodology Investigatory agents New APIs vs. Pre-approved drugs Representative sample Laboratory equipment should be tested, calibrated, and maintained according to written SOP HMA 9/26/09 19 Stability Monitor representative samples for quality and stability throughout the investigation Ensure stability when storing and shipping investigational drug Distribution includes transport to investigators and to subjects Keep distribution log detailing batch record and temperature to ensure quality HMA 9/26/09 20 How to Comply with CGMP During phase 1 clinical studies QC maintains quality and safety standards Development and Adherence to QC: Well defined written SOPs Equipment is adequately controlled Data from production and testing accurately and consistently controlled Records must be sufficient to replicate the manufacturing process HMA 9/26/

8 How to comply with the statute Have appropriate QC procedures in effect Well-defined written SOPs Adequately controlled equipment and manufacturing environment Accurately and consistently recorded data from manufacturing and testing Standards of safety, identity, strength, quality, and purity HMA 9/26/09 22 Are there any Questions? Thank you! Harvey M. Arbit, PharmD, MBA, RAC, CCRP HMA 9/26/

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