Good Manufacturing Practices for Phase I Investigational Drug Products: GMPs Required for Drug Products Used in Phase I Clinical Trials
The purpose of this webinar is to review all requirements of FDAs "Good Manufacturing Practice for Phase I Investigational Drug Products" , However, due to the length of the webinar, the GMP guidance document will be reviewed, so that attendees are clear on how to comply with FDA requirements by complying with FDA’s GMPs for Phase I Investigational drug guidance document (drug products used in Phase I clinical trials).
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Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any other time during the lifecycle of the product, that a product be safe whenever humans are being exposed to it for the first time. In any stage during the lifecycle of the drug product, a product is considered adulterated and therefore, illegal for sale, if it is not manufactured using good manufacturing practices.
Although GMPs as per 21 CFR Part 211 no longer apply to many Phase I investigational new drugs (drugs made for use in Phase I clinical trials), statutory requirements require certain information be available in an IND, which is submitted and reviewed to FDA and if it is not placed on clinical hold within 30 days, the sponsor may go forward with their clinical trials. Due to time constraints of this webinar, IND requirements cannot be reviewed.
However, the purpose of this webinar is to review all requirements of FDAs "Good Manufacturing Practice for Phase I Investigational Drug Products". This guidance applies to investigational new drug and biological products (including finished dosage forms used as placebos) intended for human use during phase I development, including but not limited to: investigational recombinant and non-recombinant therapeutic products, vaccine products, allergenic products, in vivo products, plasma derivative products, blood and blood components, gene therapy products and somatic cellular therapy products, including xenotransplantation products.
Why should you Attend: FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on human subjects for the first time, during conduct of Phase I clinical trials, which can begin if your IND is not put on clinical hold in 30 days after receipt by the FDA. If they review your IND and the appropriate information is not available to ensure FDA of the quality of the product, the IND will be placed on clinical hold, preventing your clinical program from going forward.
The necessary content of the IND will not be discussed in this webinar, but the specific GMPs for Phase I Investigational drugs will be understood by attendees, therefore allowing the applicant to apply only those GMPs which are applicable to the drug product at this stage of development, instead of trying to apply GMPs, as defined in 21 CFR Part 211, to Phase I Investigational drug products, which often leads to frustration and even errors, as the CFR definition was meant for commercial batches, which are large and repetitive, as well as different in other ways, making the application of some of the GMPs for finished drug products impossible.
Areas Covered in the Session:
Who Will Benefit:
- Statutory and Regulatory Requirements
- Personnel requirements
- QC Functions
- Facility and Equipment Requirements
- Control of Components and Containers and Closures
- Manufacturing and Records
- Testing and Stability requirements, for Laboratory Controls
- Packaging, Labeling and Distribution and also Recordkeeping
- Considerations, Adventitious Agent Control, Gene Therapy and Cellular Products with regards to Biological and Biotechnological Products
- Sterile Products and Aseptically-Processed Products and issues regarding Multi-product facilities
- Senior Quality Managers, Quality VPs
- Quality Associates or Specialists
- Regulatory Management or Regulatory Specialists
- Compliance Professionals
- Quality Auditors
- Validation Engineers
- R & D Scientists- Chemists, Geneticists, Biochemistry Specialists, Formulation Chemistry
- Laboratory Personnel
Stephanie Cooke is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms.
Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical (chemical entities and biologically-based drugs), biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, BLAs, post-marketing supplements such as CBEs, Prior approval supplements, orphan drug designation and related submissions, 510ks, PMAs and HDEs).
She also has extensive QA and validation experience, successfully hosting many regulatory audits conducted by FDA, ISO and other international regulatory bodies (Irish Medical Board and others), training personnel on hosting audits by global regulatory bodies, as well as establishing auditing programs to qualify contract manufacturers and vendors of raw materials, APIs, etc. and product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for establishing and maintaining Quality systems for all product types (CAPA, Change Control, Complaint handling, Document Control systems), stability programs, as well as preparation/performance of process validation(s), sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems, stability testing, impurities testing, analytical testing and qualification of equipment.
Stephanie has been involved in the development of drugs, including biologics, biotech products and medical devices, from product concept through post-approval maintenance including requirements for submissions for various regions/countries, process validation requirements, etc. and has considerable project management experience.
Ms. Cooke is experienced in the formulation and involved in the manufacturing process of APIs and drug products for drug and biotech products, working on CMC sections of the CTD for various countries/regions, and writing CMC sections and establishing required preclinical and clinical testing necessary. Stephanie worked for Sciele Pharma from 2005-2009 and was VP of Regulatory Affairs, Quality Assurance/Validation for Sciele, prior to leaving in 2009 to start Cooke Consulting.
She also held various senior RA, QA and validation positions at Merial, Bayer (Visible Genetics), Cryolife, Theragenics and other pharmaceutical, biotech and medical device companies, after beginning in industry as a lab tech and working as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry.