Quality Risk Management - ISPE Boston Product...

ISPE Boston Area Chapter Product Show 2017 10/4/2017

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Quality Risk ManagementIron Chef Edition

Keith D. Gibbskage and sui generisNinja Project Management

ispe.orgConnecting Pharmaceutical Knowledge

My story shapes my perspective …

• Bachelor of Science work in Earth Science withfocus on Hydrogeology. Masters of Science work inCoastal Policy and Marine Resource Management.PhD and JD work in Environmental Policy.

• Twenty‐five (25) years experience with regulatedindustries, with the first seven (7) years inEnvironmental Science and the last eighteen spentin Pharmaceutical & Biotech Manufacturing.

• Fifteen (15) years as a Project Manager, gettingfurther and further away from the details of issues,but closer and closer to the impact thatmisunderstood issues have on large projects.


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When I was in the Air Force ROTC as

a meteorology major, I looked at

the physics of airflow at a global

scale, in open systems.



After shifting to the geosciences, my

focus became more environmental policy and I worked in air quality for the EPA


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When I was in the lab, I looked at EVERYTHING

under the microscope, and

debated and discussed every

possibility ad nauseum.



As a young Validation Specialist, I was trained

to look for failure, but rarely asked to provide reasons for that failure. Discrepancy resolution fell to others, and those resolutions were often on different timelines

then mine.


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As a Project Manager in pharmaceutical

manufacturing, I now focus more on programmatic

solutions, quality by design, Quality Risk Management and

avoidance of regulatory observations. Sometimes the

view of root cause gets “clouded” when you are

looking at everything from the 30,000 foot level.

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My Days Are Spent …


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Facility Design

#1 -PROTECTING THE PRODUCT!

What Is The Driver?

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PROTECTING THE PRODUCT MEANS PROTECTING THE PATIENT

Surfaces should not be …

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REACTIVE ADDITIVE ABSORPTIVE


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PROTECTING THE PRODUCT MEANS PROTECTING THE PATIENT

So as not to alter …

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SAFETY

IDENTITY

STRENGTH

PURITY

QUALITY


THERE ARE OTHER REASONS

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FACILITY DESIGN AND CONSTRUCTION

GENERATES?

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INTRODUCTION TOQUALITY RISK MANAGEMENT


Video Clip


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History


Pharmaceutical cGMPS for the 21st Century —A Risk-Based Approach: Second Progress Report and

Implementation Plan

On February 20, 2003, the Food and Drug Administration (FDA) released its first progress report on a major initiative concerning the regulation of drug product quality. The 2-year initiative, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach (the Pharmaceutical cGMP initiative), which was launched on August 21, 2002, applies to human drug and biological drug products and veterinary drugs and has several objectives:

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Pharmaceutical cGMPS for the 21st Century —A Risk-Based Approach: Second Progress Report

and Implementation Plan

To encourage the early adoption of new technological advances by the pharmaceutical industry

To facilitate industry application of modern quality management techniques, including implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance

To encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas

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Pharmaceutical cGMPS for the 21st Century —A Risk-Based Approach: Second Progress Report

and Implementation Plan

To ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science

To enhance the consistency and coordination of FDA's drug quality regulatory programs, in part, by integrating enhanced quality systems approaches into the Agency's business processes and regulatory policies concerning review and inspection activities.

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More History


International Conference on Harmonisation

• Began in 1990

• Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

• Unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.

• ICH's mission is to achieve greater harmonisation so safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

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ICH – http://www.ich.org/


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ICH Q9 – QUALITY RISK MANAGEMENT

This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, biological and biotechnological products

Includes: raw materials, solvents, excipients, packaging and labeling materials

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• Development

• Manufacturing

• Distribution

• Inspection

• submission/review processes


ICH Q10 – PHARMACEUTICAL QUALITY SYSTEMS

• ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.

• based on International Standards Organisation (ISO) quality concepts

• includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”.

• ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.

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Even More History


GROUPS/AGENCIES THAT ISSUE GUIDELINES

American Society for Testing and Materials (ASTM)• development and delivery of international voluntary

consensus standards. (Over 12,000!)• improve product quality• enhance safety• facilitate market access and trade• build consumer confidence.

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• Application of the approach is intended to satisfy international regulatory expectations

• ensures that manufacturing systems and equipment are fit for intended use.

• satisfy requirements for design, installation, operation, and performance.

• The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach.

• This guide supports, and is consistent with, the framework described in ICH Q8 and ICH Q9.

ASTM E2500 - 07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment


CONSUMER cGMP’s

Finished Goods Manufacturers

Contract Manufacturers

Raw materials

API Manufacturing

Packers & Handlers

WHAT DOES ALL THAT GUIDANCE DO?


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The Future?


Video Clip


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PROCESS THINKING


The key to understanding the topic …

Process Thinking


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A documented, standardized set of steps to accomplish an objective.

Process Thinking


Documented And Standardized Processes

• Most processes are neither documented nor standardized.

• A documented process is one that has been explicitly described graphically or in text.

• A standardized process is one that has been made common across a number of performers; doing the same thing in a common way.

• Without documented and standardized processes people can work towards a common outcome in any number of ways.


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Documented And Standardized Processes

• the members of one department responsible for sales and service in one district may do their job following different procedures than another department doing the same thing in another district.

• Two teams may achieve their similar project outcomes using different tools and approaches.

• The process can be made common so that everyone does their work in the same way, using the same tools and templates, following the same steps.

Example…


Why Document And Standardize Processes

• Processes are any set of steps, documented, standardized or not. Documented and standardized processes are quite desirable. They are necessary parts of achieving high-quality results.

• Documented processes can be analyzed, evaluated, refined, standardized and made repeatable.


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Why Document And Standardize Processes

According to W. Edwards Deming:

“If you cannot define what you are doing as a process, you do not understand what you are doing.”

If you do not understand what you are doing, you are more likely to do it poorly – inefficiently and ineffectively.

Documentation is not the process.

The documentation describes the process; it is not the process itself. Knowing this helps performers in complex processes to expect that they should and must not stop thinking, following the process blindly. Process documentation should clearly state the risks of following and not following the process as it is written.


Standardized And Repeatable Processes

• Processes that are used across multiple departments or by many people

• make training more efficient• are easier to control and improve• enable easy transfer of people between departments or projects.

• Standardized processes are repeatable. They can be done the same way over and over again.


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Standardized And Repeatable Processes

• Standardization and repeatability are great, but they come with a warning. Make sure they are good. Clearly, you don't want to repeat a process that is ineffective or inefficient. You need to bring process quality into the picture. In addition, you must consider the conditions and build in alternative paths to address predictable alternative situations.

As said, the best people can be brought down by a bad process.


Process Thinking


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Selection of Volun“Tolds”


QUALITY RISK MANAGEMENTICH Q9 Quick Video


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QUALITY RISK MANAGEMENTIS LIKE … WORKING IN A RESTAURANT

INTRODUCING QRM:IRON CHEF


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SOME FUNNY VIDEO CLIPS TO FURTHEROUR DISCUSSION

THE PREP


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THE PRODUCTION

THE JUDGEMENT


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QUALITY RISK MANAGEMENT:LESSONS LEARNED BY YOUR SPEAKER

Q&A


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And what about that crazy conspiracy theory?

For further information please contact:

Keith D. Gibbskage and sui generisNinja Project [email protected]

Quality Risk Management - ISPE Boston Product...

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