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Best Practices, LLC Strategic Benchmarking Research

Benchmarking BioPharma

Quality and CAPA Processes

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Table of Contents

Executive Summary Pgs. 3-6

Research Overview Pg. 4

Participating Companies Pg. 5

Definitions and Abbreviations Pg. 6

Key Findings and Insights Pgs. 7-10

CAPA Benchmarks and Defining CAPA Pgs. 11-18

CAPA Effectiveness Metrics Pgs. 19-24

FDA Questions, Inspections and Observations Pgs. 25-28

Best Practices for Building a Strong CAPA System Pgs. 29-30

Quality Spend Levels and Trends Pgs. 31-36

Quality Staff Levels Pgs. 37-41

Quality Spend Mix Pgs. 42-48

Quality Reporting and Ownership Pgs. 49-53

Quality Spend Drivers Pgs. 54-59

Outsourcing Quality Pgs. 60-64

Best Practices for a Robust Quality Function Pgs. 65-66

Demographics Pgs. 67-71

About Best Practices, LLC Pg. 72-73

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Field Research & Insight Development:

Best Practices, LLC recruited Quality function and

CAPA Process executives at 14 biopharmaceutical

organizations to share their data and insights in a

customized benchmarking study.

Respondents were surveyed through an online

benchmarking instrument, validated through

telephone conversations. Top performers were

engaged via phone interviews.

Assist companies in achieving top-

tier performance in three important

areas critical to Quality:

• CAPA Process Management

• CAPA Performance Benchmarks

• Quality Resource Management

Research Objectives & Methodology

Research Objectives:

Business Objective:

This benchmarking initiative focuses on:

Assessing CAPA processes

Uncovering strong benchmarks for CAPAs, NCEs, FDA Questions, Inspections

and Observations

Defining CAPA effectiveness metrics

Measuring the true cost of Quality

Highlighting strategies to manage quality costs and align spend mix

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Universe of Learning: 14 BioPharma Companies Participated

This benchmarking study engaged 14 executives from leading biopharmaceutical organizations. Data

is charted throughout this report for the “Total Benchmark Class” (TBC) as well as for the “Large

Company Segment” (LCS), which includes 9 companies with biopharmaceutical revenues above $5B.

Large Company Segment • Associate Director, Process

Excellence

• Director, Global CAPA and Change

Control

• Vice President, Quality

• Director of Quality

• SVP, Quality

• Director, Quality

• Executive Director, Quality

• Head of Quality, Biotechnology

• Director, Supply Chain

Management

• Director, Continuous Improvement

• Sr. Director, Quality Assurance

• Director, Quality Assurance

• Sr. Director, QA

• Sr. Manager

Participant Titles Total Benchmark Class

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Definitions and Acronyms

Management

Factors

Process

The following definitions and acronyms were used in this research study.

• CA: Corrective Action

• CoQ: Cost of Quality

• FTE: Full-time Employees

• LCS: Large Company Segment

• NCE: Non-Conforming Event

• PA: Preventive Action

• Q FTE: Quality FTEs

• Q Spend: Quality Spend

• Q: Quality

• QMS: Quality management System

• TBC: Total Benchmark Class

Key Findings & Insights: Benchmarking BioPharma Quality and CAPA Processes

Volume of Open CAPAs: The way that companies define start and end points of CAPA plays

a critical role in understanding the CAPA success of the companies.

While companies with strict definitions of CAPA end points may have high number of open

CAPAs, the companies with loose end point definition may end up having less open CAPAs.

As a result utilizing a wide range of different metrics to provide deeper information about CAPA

process effectiveness and minimize the effects of definitions on CAPA measures are critical.

CAPA Effectiveness: Companies are still trying to find the best ways to measure

effectiveness of their CAPA processes. There can not be “one size fits all” approach, because

of the differences in products and processes of the companies.

We observed that benchmarked companies fall behind in preventive activities, since the

targeted ratio of preventive actions is higher than the actual.

Quality Spend & Staff Levels and Trends: Complexity factors, regulatory restrictions and

process management factors are the top areas that effect Quality resource levels. To ensure

lower costs, companies must manage the factors that they can have high control on.

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Companies Moving Toward Earlier Management of CAPAs

Fifty-Six percent of TBC defines Entrance of the Information into the Quality Management System as the

CAPA start point, while one-third uses Discovery of an Event as the start point of CAPA. Companies

using Discovery as a CAPA start point event typically report superior corrective vs. prevention metrics.

Q22. Start and End Point of a CAPA: How do you define the start and end of a CAPA in your organization?

N=9

Other response: “During and after investigation of an unplanned deviation.”

Investigation

Necessity of CAPA(s) (Yes/No)

If Yes, Put in QMS System

Entrance into QMS System

Investigation

Implementation

QMS Start Point Discovery Start

Point Discovery of an

event 33%

Entrance of the information into

the Quality Management System Tool

56%

Other 11%

CAPA Start Point

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Top CAPA Effectiveness Metrics: Recurrences and Repeats

More than half of the benchmark class uses Number of Recurrences and Number of Repeats to

measure effectiveness of CAPA processes.

Q25. CAPA Effectiveness: Please select the metrics that you use to measure your CAPA effectiveness.

N=8

88%

75%

50%

50%

38%

38%

38%

25%

13%

Number of recurrences

Number of repeats

Completion of action timelines

Frequency of non-conformances

Frequency of complaints confirmed as nonconformance

Frequency or number of product recalls

Complaint closure timelines

Frequency or number of investigations which reach rootcause

Investigation timelines

CAPA Effectiveness Metrics - TBC

% Respondents

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A Strong CAPA System is Critical for the Success of Quality Function

Management

Factors

Process STRONG

CAPA

SYSTEM

Align Definitions:

Aligning definition

of CAPA with the

performance

evaluation metrics

is critical to

understand

success of CAPA

processes

Adjust CAPA

Processes: It is

important to adjust

CAPA processes

with the product

portfolio and

complexity factors

to hit CAPA targets

Increase

Prevention: High

preventive-action

ratios allow

companies to avoid

future corrective

actions

Use the Right

Metrics:

Identifying metrics

that align with the

company targets is

critical for the

success of CAPA

processes

Keep Strong

Records: Keeping

exact records with

proper tracking of

all the CAPA

related events aids

early identification

of issues

Maintain

Conformance with

Regulations:

Ensure that

implementation and

effectiveness of

CAPA aligns with

regulatory

demands

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Choose the Right CMO to Avoid Outsourcing Failures

An important component of outsourcing is working with CMOs. It is critical for companies to create a

high set of standards when choosing the CMOs that they work with.

Identifying

manufacturing

capabilities

Experience

with the

company’s

products

Understanding

the strength of

Quality system

within the

CMO

Registration to

the country’s

regulatory

body Alignment

between the

capacity of the

CMO and the

company’s

demand

Understanding

of deviation

reporting and

investigation

Pathway to

choose the

right CMO

Choosing the Right CMO

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85%

85%

86%

88%

88%

91%

98%

17%

15%

16%

14%

14%

9%

2%

Regulatory Affairs

Training

Audit Management (Internal and External)

Operational Excellence/ Continuous Improvement

Operational Excellence/ Continuous Improvement

Compliance

Quality Assurance

Outsourcing Quality - TBC

% of Activities Done In-House: % of Activities Outsourced

A Majority Utilizes In-House Quality Capabilities

More than 90% of the benchmark class manage Quality Assurance and Compliance activities in-house.

In addition, more than 80% of the TBC do not outsource other activities.

N=9

Q17. Managing Quality Labor Costs: Please estimate the percentage of total Quality

activities that are done in-house vs. outsourced.

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About Best Practices, LLC

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Best Practices®, LLC is an internationally recognized thought leader in the field of best practice

benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that

conducts work based on the simple yet profound principle that organizations can chart a course to superior

economic performance by leveraging the best business practices, operating tactics and winning strategies of

world-class companies.

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Chapel Hill, NC 27517

(Phone): 919-403-0251

www.best-in-class.com

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