Guidance for Industry, CGMP for Phase I Investigational Drugs” will be covered, in order to under the requirements, as well as recommendations for complying with the level of GMPs required for manufacturing of Phase I investigational drug products. 

Based on statutory requirements Section 501(a)(2)(B) of the Food, Drug & Cosmetic Act, drugs, including those manufactured for use in all phases of clinical trials conducted per an IND, are considered adulterated if they are not manufactured in accordance with good manufacturing practice (GMPs). FDA issued cGMP regulations that applied to drugs, including chemically-synthesized and biological drugs, in all phases of pharmaceutical production, in 21 CFR Parts 210 and 211. Based on certain requirements in 21 CFR Part 211, which implement Section 501(a)(2)(B) of the Act, being directed at the commercial manufacture of drugs, which is typically characterized by large, repetitive, commercial batch production and GMP requirements, they were many issues with the application of GMPs to the manufacture of most investigational drugs used in Phase I clinical trials. Therefore, many drug products manufactured for use in Phase I clinical trials were exempt from GMPs, as defined by 21 CFR Part 211. However, in order to protect the safety of the human subjects enrolled in clinical trials, FDA issued regulations regarding specific chemistry, manufacturing and controls (CMC) information to be included in an IND submission, which allows FDA to determine if the drug product manufactured for Phase I clinical trials is sufficiently safe to allow the clinical trial to proceed. Upon review, if FDA determines that inadequate or insufficient information demonstrating that the product is safe, they will put the IND submission on “Clinical Hold”, preventing any clinical trials to proceed until the hold is removed or may even terminate the IND. In addition, to assist manufacturer’s in applying GMPs to products produced for use in Phase I clinical trials, FDA published a Guidance for Industry. “CGMP for Phase I Investigational Drugs”. The purpose of this guidance document is to understand the GMP requirements based on this guidance document and other applicable documents. 

This webinar is appropriate for individuals at various levels, as personnel may benefit from attending the webinar for variety of different reasons. Those scientists, quality, operations, laboratory analysts or other specialists involved in product and process development, for either a drug or biological drug product/biotech product development, including formulation scientists, chemists, pharmacists, life scientists, subject matter experts, quality personnel, process engineering personnel, or others may benefit from understanding the requirements during Phase I clinical trials, when the API and the process may still change, would benefit by understanding GMP and IND CMC data requirements.

In addition, quality personnel/management responsible for internal auditing or auditing a vendor for compliance, or even those that may be subjected to an audit, as oftentimes, the auditor may be auditing to 21 CFR Part 211 requirements, which are inappropriate for a facility that is in the process or will be in the process of manufacturing Phase I investigational drug products for phase I clinical trials. Quality personnel, Quality Management, as well as Operations personnel, who may be responsible for input/signing off on documents that you use, at this stage, to manage change or personnel responsible for the change control or other system used to manages changes to the process, product, etc.

In addition, those responsible for the CAPA system, either establishing a CAPA system or providing input, would benefit from this webinar as well. Personnel responsible for documentation of the process controls and those involved in establishing the initial critical process parameters, in-process controls, critical quality attributes, and those documenting all data for the manufacturing process, which must be done, even at this stage, would benefit by attending this webinar. Personnel responsible for clinical trials, either internal personnel and personnel working for CROs and personnel employed by CMOs would benefit by attending. Personnel new to company, such as those in the Manufacturing, Validation, Quality Engineering Department, Research and Development or those new to Quality or Regulatory would benefit by attending this webinar, as all personnel are responsible for GMPs.