February 23 24, 2015 Cape Canaveral, FL · February 23–24, 2015 • Cape Canaveral, FL MHRA Warns...

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. Pearce Executive 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

External Internal

Quality



Finished Product Raw Materials

API

Excipient

Packaging

Distribution Delivery Use

GMP GIP GDP

GPP Pharmacovigilance

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 Needles Counterfeit batch of insulin pen needles found

circulating in UK supply system The 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.

14

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


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

Fai

lure

s



RISK-BASED APPROACH

Spend/Leverage

Criticality Low High

Quality Performance

Environment

Good Poor

Little Much

Stable Unstable

less

fre

quent

more

fre

quent



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



Qualification

& Validation

Lead

ers

hip

Policy and

Strategy for

GMPs

Resources

GMP

Compliance

Personnel

Orientation

Current Auditing

Coverage moving towards broader scope

RISK-BASED APPROACH

Investigation System & Improvement

Ris

k M

anag

em

ent

Pro

cess

es

Contr

ols

and A

ctual

Cap

abili

ty

Busi

ness

Resu

lts

(KPIs

)

Enablers Results

General

System

Inputs

and

Outputs

Elements needed

for full PDCA

Closure

Total Quality Management

Supplier Evaluation Evolution:



RISK-BASED APPROACH

Supplier

Impact

Evaluation

Investment

Supplier Impact-Investment Map



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


• ‘Virtual’ replaces ‘Desktop’

• True ‘Remote’ Audits

• Both quantitative and

qualitative

• Results trigger next steps




Helping answer two key questions:

• Is the program on track?

• What is the program telling us?




Data Analytics aim to create

‘Supply Chain Intelligence’




Quality / Performance Are 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 and Quality

Development



Finished Product Raw Materials

API

Excipient

Packaging

Distribution Delivery Use

GMP GIP GDP

GPP Pharmacovigilance

QUALITY IN THE PRODUCT CHAIN



TODAY

Forces impacting


manufacturing

New Technology

Internal Change

External Threat


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!



GBP • Complex environment

• Detailed requirements

• Simple trigger

• Action

February 23 24, 2015 Cape Canaveral, FL · February 23–24, 2015 • Cape Canaveral, FL MHRA Warns...

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Transcript of February 23 24, 2015 Cape Canaveral, FL · February 23–24, 2015 • Cape Canaveral, FL MHRA Warns...