Which GMPs Apply Since Most Phase I Drugs are Exempt from Full GMP Requirements, and What IND Data Requirements Are Necessary as a Result?

An understanding of the GMPs that apply to Phase I drugs is necessary for professional in the clinical trials area for many reasons. With the FDA setting out rules under which most Phase I Drugs are exempt from full GMP requirements in 21 CFR Part 211 under 21 CFR 210.2(c), and with the subsequent IND data requirements; both applying GMPS when they are not required or not applying them when they are required result in considerable waste of resources and increase the chances of FDA actions.

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The operating guidance document set out by the FDA in this regard is the guidance document, “Good Manufacturing Practice for Phase I Investigational Drug Products”. This document relates to the correct GMP requirements that drug products made for the purpose of using an investigational drug product on human subjects for the first time should follow during conduct of Phase I clinical trials.

When does the FDA put the IND on clinical hold?

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If the FDA does not put an IND on clinical hold up to 30 days of receipt; it is assumed that the Phase I clinical trial can begin. The FDA puts an IND on clinical hold if it reviews an IND and finds that the information necessary and appropriate to give the FDA the confidence about the quality of the product is inadequate or unavailable. When the FDA puts an IND on clinical hold, the sponsor cannot go ahead with its clinical program. The criteria under which the FDA places an IND on clinical hold have been set out in its Guidance for Industry, the “INDs- Approaches to Complying with CGMP During Phase I”.

All the requirements for meeting the cGMPs with which clinical trial sponsors must comply have been set out by the FDA in its Final Rules of January 2006, which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements. Further, Section 501(a)(2)(B) of the FD&C Act mandates drugs, including IND products, to comply with cGMPs, and to be manufactured in compliance with cGMPs, failing which, they are deemed adulterated.

Get to understand the exemptions set out in 21 CFR Part 211

So, it is crucial for clinical trials sponsors to get a clear grasp of the requirements for an IND Phase I clinical trials, if they have to meet the FDA’s requirements. An in-depth understanding of this very important learning will be given at a two-day, in person seminar that is being organized by the highly reputable provider of professional trainings for all the areas of regulatory compliance, GlobalCompliancePanel.

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The Director of this very valuable seminar is Stephanie Cooke, President and CEO of Cooke Consulting Inc. For about two decades, Stephanie has been providing 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.

She has extensive experience in the core areas of clinical trials, such as 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).

Guidance which helps avoid unnecessary and repetitive batch productions

Stephanie will explain the specific GMPs for Phase I Investigational drugs, which will help them apply only those GMPs which are applicable to the drug product at this stage of development. This knowledge will help them avoid large, repetitive, commercial batch production and requirements, not to speak of the frustration and loss of resources this would entail.

Stephanie will also offer a complete understanding of all current Good Manufacturing Practices that are applicable to the manufacture of Phase I investigational drug product, in accordance with the FDA’s additional Guidance for Industry, “CGMP for Phase I Investigational Drugs”, which it issued in July 2008 with the purpose of providing guidance to sponsors regarding meeting GMPs appropriate for Phase I investigational drug products.

Drugs and Biologics Pharma Regulations