Course “Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). There are certain requirements in 21 CFR Part 211 that are directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production and requirements as a result, are not appropriate to the manufacture of most investigational drugs used for phase I clinical trials. Based on these issues, application of cGMPs to Phase I investigational drug products was exempted from 21 CFR 211. However, based on statutory requirements as given in Section 505(i) of the FD&C Act, FDA issued regulations governing IND products in order to protect human subjects enrolled in clinical trials, specifically with regards to the chemistry, manufacturing and controls data submitted as part of IND applications for drugs or biological products.
Subsequent to FDAs final rule of January 2006, FDA released the Guidance for Industry, “INDs- Approaches to Complying with CGMP During Phase I”. This document describes the CMC data necessary for inclusion in the IND. FDA reviews the IND to determine whether phase I investigational drugs to be used in the clinical trial to permit the trial to proceed, which is partially dependent on whether the product has the identity, strength, quality and purity and purported effect described in the IND application. FDA can chose to place the IND on clinical hold or could terminate the IND based on their review. If an IND is placed on clinical hold, the hold may be removed if the sponsor addresses the deficiencies, but clinical trials may not progress until the clinical hold is removed.
In July 2008, FDA issued an additional Guidance for Industry, “CGMP for Phase I Investigational Drugs”, in order to provide guidance to sponsors regarding meeting GMPs appropriate for Phase I investigational drug products. In this seminar, the attendees will gain a complete understanding of all current good manufacturing practices that are applicable to the manufacture of Phase I investigational drug product, in addition to understanding which products were exempt and which were not. The attendees will gain an understanding of CMC data necessary for the preparation of an Investigational New Drug application, and have an understanding of the requirements of the document and therefore avoid clinical holds or termination of the IND. Additionally, based on the products that were exempted from GMPs as defined in 21 CFR part 211, several guidance documents were created to provide guidance regarding the content and format of the CMC information necessary for inclusion in the IND for the following products: for Phase I, studies of drugs, including well-characterized, therapeutic, biotechnology-derived products, for somatic cellular therapy and for human gene therapy INDs.
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.
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