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 http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900695SEMINAR?GMP-regulatory-expectations-San-Diego. 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:

o   Very Early Stages

o   GLP requirements

o   Early Pre-IND Studies

o   Meetings and Preparing for the IND

o   GMPs for Phase 1 IND products

o   Requirements for Phase 2 INDs

o   Preparing for IND Meetings 

Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right.

FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, prosecutions, or recalls or consent decrees if serious violations are discovered at inspections. How does one inculcate the FDA line of thinking on compliance? Organizations need to first get an understanding of what the FDA looks for and keep these in compliance.

The core of all compliance activity is possession and demonstration of control over the company’s Quality System. When an organization shows this using the subsystem approach; it gives the FDA fewer opportunities to cite minor deviations from the quality system regulation. This is the basis to avoid being cited for more serious systemic deviations from the regulation.

Gaining understanding through training

Proper training on these aspects goes a long way in helping organizations steer clear of issues that give an opportunity for the FDA to take these actions. A two-day seminar from GlobalCompliancePanel, a well-known provider of professional trainings in the regulatory compliance area, will be of immense value in helping professionals get a clear idea of how to get their compliance requirements right.

Just log on to 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900523 to learn about the ways of getting into the FDA’s line of thinking on compliance. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

The Director of this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services, will offer a clear understanding of all the critical components of dealing with an FDA inspection, such as:

FDA History, Inspectional Strategy and Techniques

• SOPs
• Training
• Audits
• Managing the Inspection and State of Readiness
• Responding to FDA Inspectional Observations (483s)/Warning Letters
• Mock Inspections
• Compliance Program 7356.002, Drug Manufacturing Inspections and other Compliance Programs Device Manufacturing Inspections
• IOM (Investigations Operations Manual)
• RPM (Regulatory Procedures Manual)
• Field Management Directives
• Inspection Technical Guides and official documents used as reference material for investigators and other FDA personnel

Warning Letter and Notice of Violation Responses/Communicating with FDA

• Strategy and Remediation Implementation
• Drafting
• Liaison with FDA to ensure Close-out
• Effective Responses

State of Readiness/Practice/Mock Inspections

• Prepare for "real" inspections by being ready and not caught off guard
• Practice Sessions and Dress Rehearsals on Day Two

Japanese Institutions and Regulatory Authorities

Japanese institutions and regulatory authorities are organized in a rather complex way, with a few institutions and regulatory authorities being responsible for the oversight of regulating pharmaceuticals, and a few others, purely for developing pharmaceuticals.

The overall regulator of the Japanese institutions and regulatory authorities is the Japanese Ministry of Health, Labor, and Welfare (MHLW), which is an offshoot of the Ministry of Health and Welfare (MHW), with which the credit for framing and implementing most of the current regulations lies.

Japanese institutions and regulatory authorities for regulating pharmaceuticals

The Pharmaceutical and Food Safety Bureau (PFSB), which comes under the MHLW, is the pharmaceutical regulatory authority of Japan. This body is the one that takes decisions relating to application approval.

In addition, Japanese institutions and regulatory authorities consist of two other bodies that work with the pharmaceutical industry on a day-to-day basis. These are:

Although it is admitted that the organization of Japanese institutions and regulatory authorities in such a manner is rather confusing and an effort is underway to merge these three institutions; as of now, this is yet to materialize. There has been some ongoing movement towards creating a superstructure of these three Japanese institutions and regulatory authorities, creating an FDA-like body.

Japanese institutions and regulatory authorities in relation to development of pharmaceuticals

Japanese institutions and regulatory authorities in relation to development of pharmaceuticals are organized in the following manner:

Read More:https://www.linkedin.com/pulse/japanese-institutions-regulatory-authorities-ronald-gardner?trk=prof-post