Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

Although these new guidelines appear to remove the need to follow GMPs for Phase I products; the same still exists in the Food, Drug, and Cosmetic Act. As a result, the need for GMP requirements for Phase I products has not been done away with; rather, it has been altered. Now, the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.


Get trained to understand these aspects

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar to help Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control get a grasp of these aspects. To enroll for this highly valuable training, please log on to Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director of this webinar.

Advice on the GMP guidance document

This presentation, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion, will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. In one source, it will present the regulations and guidelines that apply to early phase products. In some cases these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Steven will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.


This course is very useful for any pharmaceutical personnel who must deal with products both in early and later phases of development, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar.

It will cover the following areas:

  • Very Early Stages
  • GLP requirements
  • Early Pre-IND Studies
  • Meetings and Preparing for the IND
  • GMPs for Phase 1 IND products
  • Requirements for Phase 2 INDs
  • Preparing for IND Meetings

API Process Inspection –what does the FDA expect?




API Process Inspection –what does the FDA expect?

Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to.

The FDA and API Process Inspection

Rules regarding what the FDA expects are mentioned clearly in the document that lays down the principles of an FDA API process inspection, namely FDA Program Guidance Manual (Program 7356.002F). So, the FDA sticks to what is prescribed in this document:

–        GMP is a must for the FDA

–        It recognizes Q 7 as the primary API GMP. If you cannot follow Q 7, you can expect an equivalent activity, but are expected to demonstrate that the alternative activity you used did not in any way violate the basic requirements set out in this document.

–        This program manual is applicable for API manufactured by synthesis/fermentation and not for dosage forms

–        This document applies to domestic and foreign inspections

–        Uses a six-system approach

Other requirements

–        Expects compliance with FDA regulations

–        Compliance with Q 7 or equivalent

–        Procedures and documents must be clearly written down

–        Should have appropriate Quality System in conformance with Q 7, to ensure that an international or domestic guidance is adhered to

–        Should have sound Quality Practices

–        A sound and documented QMS that is “shown to work”

–        Appropriate Change Control Systems

–        Cleaning systems and records

–        Appropriate Validation and Qualification performed and documented

–        Written contracts and Quality Agreements where appropriate

–        Auditing programs and documentation

Systems that will be examined

During an FDA API process inspection, it inspects the following types of systems:

–        Quality System

–        Facilities and Equipment

–        Materials System

–        Production

–        Packing and labeling

–        Laboratory Control System




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