The Ethics of Compliance:Current Good Manufacturing Practices (cGMPs) and the

Food and Drug Administration (FDA)

manningmitch@aol.com

Learning Objectives• Learn the seven values of cGMP compliance for the

21st century • Learn the two keys and four steps to successful

cGMP inspections• Review the five levels of leadership for cGMP

compliance• Learn to mindread the FDA Readiness team• Learn to mindread the FDA Investigators• Learn the top 10 things not to do during an FDA

Investigation• Learn the five keys for converting organizational

values to cGMP ethics

• The “Forrest Gump” Of SlideShare • Willing To Share His Opinions, And Experience• Enjoying Watching From the Sidelines• Gifted at Using Your Watch To Tell You The Time

Presenter Disclosureor, Truth In Presenting

Mitch Manning is

Ethics DrivenConsumer Protection

The Seven Values of cGMPs for the 21st Century

CommunicationEducation

HarmonizationInnovation

DeterminationReputation

Documentation

Ethics DrivenConsumer Protection

The Seven Values of cGMPs for the 21st Century

CommunicationEducation

HarmonizationInnovation

DeterminationReputation

Documentation

Why Concern Ourselves With Values and Ethics?

• Attitude• Expectations• Approach• Deployment• Results• Compliance• Progress• Work/Life Balance

Clear, Concise and Correct

Quality Values and Ethics

• Guide people, procedures, and programs• Provide the context for ethical behavior• Are the grounding point for cGMP values• Help clarify and separate right from wrong• Shelter people in challenging times• Motivate and inspire people in all situations

Two Keys to CGMP Compliance

Attitude – First PriorityAptitude – Second Priority

Four Steps to Successful cGMP Inspections

WhatWhyHow

Execution

A Borrowed Process Model forEthical Behavior

Added by Mitchell W. Manning, February 2, 2005

Organizing for cGMP Compliance:

Four Cultural Elements of cGMP Compliance

LanguageTechnologyInstitutions

Art

Eight Guiding Principlesfor Designing Ethics Into cGMP

Compliance

1. Quality values must be freely chosen from alternatives. 

2. Quality values must be consistent with the purpose of the systems based program, and the sponsoring organization. 

3. Quality values must be clear, concise and correct. 

4. Quality values must be actionable. 

Eight Guiding Principlesfor Designing Ethics Into cGMP

Compliance

5. Quality values must enhance performance.

6. Quality values must be attractive and pride-giving. 

7. Quality values must be capable of being communicated. 

8. Quality values must be prominently displayed.

Personality, Procedure & Power

Five Levels of Leadership for cGMP Compliance

GestaltWisdom

PersuasionSeduction

Force

Who Is On Your Team?1. Shared Goals and Values2. Sense of Control and Accountability

Free Agent

Dead Weight

Partner

Loyalist

2

1 High

High

How To Mind Read The FDA Readiness Team:

Team Building On Personality Strengths

• Dominance• Influence

• Conscientiousness• Steadiness

Appreciate Human Diversity

Know the team’s personalities

Personality Strengths Stressors Goals Fears

Dominance Initiative Loss of control Control Being taken advantage of

Influence Enthusiasm Loss of approval

Approval Being rejected or disliked

Steadiness Follow-through Loss of predictability

Stability Being asked to change

Conscientiousness Thoroughness Loss of personal privacy

Quality Being criticized for poor quality

How To Mind Read The Investigator(s):

Five Areas of Predictability

Purpose of the “Visit”Team Composition

Years of FDA ServiceWalk-Through Behaviors

Requests

Why cGMP Inspections Fail:The Top Ten Things Not To Do

LieCheatSteal

UnderestimateOver PromiseUnder DeliverProcrastinateLook Down

WhineAvoid

Converting Organizational Values to cGMP Compliance Ethics:

Five Keys

IlluminateCommunicate

MotivateEducate

Administrate

Quality Idealsof America’s Most Admired Companies

• Innovation• Employee talent• Use of corporate assets• Social responsibility• Quality of management• Financial soundness• Long-term investment value• Quality of products and services

Source: Fortune, magazine

Dominant Global Values

• Fast• Cheap• Perfect• Personalized• Unique

When In Rome…

The following remain our guiding principles:

. Risk-based orientation

. Science-based policies and standards

. Integrated quality systems orientation

. International cooperation

. Strong public health protectionSource: Final Report – Pharmaceutical cGMPs for the 21st Century, September 2004.Our findings have put the Agency on a path to restructure its oversight of pharmaceutical quality regulation, thereby developing the

product quality regulatory system of the future. The following remain our guiding principles:

Website: http://www.fda.gov/cder/gmp/gmp2004/CGMP%20report%20final04.pdf

cGMP Quality Systems

Quality System’s Sub-systems

Design ControlsDesign Controls

MaterialMaterialControlsControls Records,Records,

Documents, &Documents, &Change ControlsChange Controls

Equipment & Equipment & Facility ControlsFacility Controls

Production & Production & Process ControlsProcess Controls

Corrective &Corrective &PreventivePreventive

ActionsActions

ManagementManagement

Opportunities for Designing Ethics Into FDA Regulated Systems Based Programs

• Enabling Technology Development and Innovation

• Patient and Consumer Protection• Protecting the Homeland – Counter terrorism• Using Risk-Based Management Practices• Empowering Consumers for Better Health• Improving FDA’s Business Practices

Source: Food and Drug Administration Progress and Priorities 2004, September 2004

Back Ground Information

www.fda.gov

http://www.fda.gov/oc/crawford/default.htm

http://www.fda.gov/oc/initiatives/reports/priorities2004.html

http://www.fda.gov/oc/crawford/speeches.html

http://www.fda.gov/opacom/hpview.html

Learning Objectives• Learn the seven values of cGMP compliance for the

21st century • Learn the two keys and four steps to successful

cGMP inspections• Review the five levels of leadership for cGMP

compliance• Learn to mindread the FDA Readiness team• Learn to mindread the FDA Investigators• Learn the top 10 things not to do during an FDA

Investigation• Learn the five keys for converting organizational

values to cGMP ethics

Designing Ethics Into cGMP Compliance to be the Frontline for Consumer Protection

Conclusion• Know what you want.• Know when you have to have it.• Know what you are willing to pay.

Parting AdviceDo the right thing.Do your very best.

Do good for others.

Questions?

You Make The Call

• National Device Expert on Warning Letters• National Drug Expert on 483s• National Drug Expert on Validation• Recall Coordinator on Recalls• Investigator on PADE Investigations