quality manufacturing in healthcare asq 2015

22nd Annual Conference on Quality in the Space and Defense Industries

February 23–24, 2015 • Cape Canaveral, FL

Manufacturing in

the Healthcare

Industry:Quality Challenges

and Tools

Gerard J. PearceExecutive Vice President

SQA Services, Inc.





Forces impacting

Quality in healthcare

manufacturing

New

Technology

Internal Change

External Threat

Tools and

Techniques for

Quality

Adaptation

Prioritization

Optimization

TODAY

Objective Focus



HEALTHCARE QUALITY PLAYING

FIELD

• Highly regulated, and focused on patient

safety

• Conservative, risk-averse

• Relatively long development cycle

• Innovation emphasis on R&D

N Engl J Med 2013; 368:2043-2045



ANTICIPATING

QUALITY

NEEDS

• FDA working to respond

to, anticipate, and help

drive scientific

developments

• FDA defining and

clarifying regulatory

pathways and policies

• Establishing a basis for

Quality professionals to

anticipate and prepare

for the changes to come

with new technologies



HEALTHCARE QUALITY INFLUENCERS

Parenteral Drug Association



QUALITY FOCUS

• Best patient and business outcome

• Regulatory, in conjunction with FDA goal

that “products consistently meet applicable

requirements and specifications”

• Environmental (Internal)

• Environmental (External)Regulatory

ExternalInternal

Quality



Finished ProductRaw Materials

API

Excipient

Packaging

Distribution Delivery Use

GMPGIP GDP

GPPPharmacovigilance

QUALITY IN THE PRODUCT

CHAIN



REGULATORY INITIATIVES

• FDA Safety and Innovation Act 2012 (risk

management, global focus, enhanced

tools)

• FDA Drug Quality and Security Act 2013

(Track and Trace)

• EMA Falsified Medicines Directive 2013

(authenticity, controls, documentation)

• FDA Unique Device Identification

Guidance 2014 (safety, surveillance)



COMMERCIAL CHANGES

• Actavis – Allergan

• Pfizer – Wyeth

• Glaxo Wellcome – SmithKline Beecham

• Teva – Barr

• Merck – Schering-Plough

• Abbott – Solvay

• etc.



SAFE

SUPPLY

FOCUS• Extended supply

chains

• Growth in

outsourcing

• Decentralized

controls



COST OF POOR QUALITY



QUALITY FAKES



MHRA Warns Diabetics About

Counterfeit Insulin Pen NeedlesCounterfeit batch of insulin pen needles found

circulating in UK supply systemThe Medicines and Healthcare products Regulatory

Agency (MHRA) is today warning diabetics about a

counterfeit batch of insulin pen needles that are

circulating in the UK.

13

May 7, 2007

80 children die in Haiti due to contaminated

glycerin in acetaminophen syrup

COST OF POOR QUALITY



QUALITY CONCERNS

• Fast changes, slow industry

• Interpretation of standards

– Client-specific needs

– Controlling quality at contract

manufacturers

• Supply Chain globalization

• Other:

– Security

– Managing ‘end-of-cycle’



SUPPLIER EVALUATION• Supply chain is a moving target

• Distance, language, culture and local

knowledge

• CAR Sickness

• ‘Standard’ Tools and Systems

• Quality-Supply Management disconnect



Forces impacting


manufacturing

New

Technology

Internal Change

External Threat

Tools and

Techniques for

Quality

Adaptation

Prioritization

Optimization

TODAY

Objective Focus



ADAPTING TO CONDITIONS

• Risk-based approach

• Harnessing best practice and technology

• Social Media and Industry Collaboration

• Structure for Success



RISK-BASED APPROACH

• Focus based on status and risk

• Strategic Partners

• Strategic Stinkers

• Regional Coverage

low medium high

high

medium

low

Criticality

Failu

res



RISK-BASED APPROACH

Spend/Leverage

CriticalityLow High

Quality Performance

Environment

Good Poor

Little Much

Stable Unstable

less fre

qu

en

t

more

fre

qu

en

t



RISK-BASED APPROACH

High-level look to low-level look:

1. ‘D&B-style’ check

2. Self- or desk-audit

3. ISO-style audit

4. Specialized audit

5. Assessment



Qualificatio

n

& Validation

Leaders

hip

Policy and

Strategy for

GMPs

Resources

GMP

Compliance

Personnel

Orientation

Current Auditing

Coveragemoving towards broader

scope

RISK-BASED APPROACH

Investigation System & Improvement

Ris

k M

anagem

ent

Pro

cesses C

ontr

ols

an

d A

ctu

al

Capabili

ty

Busin

ess R

esults

(KP

Is)

Enablers Results

General

System

Inputs

and

Outputs

Elements needed

for full PDCA

Closure

Total Quality Management

Supplier Evaluation Evolution:



BEST PRACTICE AND

TECHNOLOGY

• Supplier review and rationalization

• Deeper supplier scrutiny

• Quality Agreements

• Common-sense controls

• Tracking and Screening Methods



XY RSA

BC Plan.pdf

BEST PRACTICE AND

TECHNOLOGY• ‘Virtual’ replaces ‘Desktop’

• True ‘Remote’ Audits

• Both quantitative and

qualitative

• Results trigger next steps



BEST PRACTICE AND

TECHNOLOGYHelping answer two key

questions:

• Is the program on track?

• What is the program telling

us?



BEST PRACTICE AND

TECHNOLOGY

Quality / PerformanceAre they succeeding?

External

factors- Are they

impacted by the

environment?

Compliance- Are they set up to

succeed?

Criticality

- how important are they?

Overall Risk

Supplier Scorecard

Supplier Dashboard

Supplier Quality Profile

…others?

Integrating supply chain data:



SOCIAL MEDIA & INDUSTRY

COLLABORATION



STRUCTURE FOR SUCCESS

Balance between:

Inspections

Non-conforming product

Supplier Corrective Action

Material returns

Quality Agreements

Supplier Scorecards

Supplier Consolidation

Supplier Qualification

Supplier Audits & Assessments

Supplier Remediation

Quality

Control andQuality

Development



Finished ProductRaw Materials

API

Excipient

Packaging

Distribution Delivery Use

GMPGIP GDP

GPPPharmacovigilance

QUALITY IN THE PRODUCT

CHAIN



TODAY

Forces impacting


manufacturing

New

Technology

Internal Change

External Threat

Tools and

Techniques for

Quality

Adaptation

Prioritization

Optimization

Objective Focus



RECOMMENDED READING

• Dangerous Doses – Katherine Eban

• The Signal and the Noise – Nate Silver

• Single Point of Failure – Gary Lynch

• Reinventing Discovery – Michael Nielsen

• Phake – Roger Bate





Questions and further information:

Gerard Pearce

310-802-4448

[email protected]

THANK YOU!

quality manufacturing in healthcare asq 2015

Healthcare

cape canaveral

defense industriesfebruary

quality challenges

quality professionals

fl22nd annual conference

fl225201511 quality

enhanced toolsfda drug

healthcare industry