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ISPE Quality Metrics Program –
An Update
Diane Hagerty, Genentech / Roche
Vice President, Global Quality Systems & Processes
17 September 2014
• ISPE Quality Metrics Program
• Overview
• Quality Metrics Industry Pilot
• Quality Performance Metrics
• Status
• Next Steps
2
ISPE Quality Metrics Program
To produce a “white paper” acceptable to industry on quality metrics,
which could be reportable to the FDA to support a risk-based inspection
program included in Sections 704 to 706 of US FDASIA.
The “white paper” should:
• Identify proposals targeted for discussion with the FDA and potentially with other
agencies.
• Justify why certain metrics are proposed, considered or rejected
• Justify the choice of site based and/or product-based metrics
• Comment on the relevance of and/or relationship to data already provided to
regulatory agencies, e.g., Field Alert Reports
• Be published on ISPE website
FIRST GOAL
G U I D I N G P R I N C I P L E S
• Clearly defined to allow consistent reporting across sites
• Objective and Meaningful
• Easy to Capture
• Easy to Report
• “Normalized” based on factors such as process differences
and technical complexity
Drive acceptable, not unwanted behaviors
ISPE Quality Metrics Program
W H I T E PA P E R
R E C O M M E N D AT I O N S
ISPE Quality Metrics Program
• Conduct a Pilot to ”flesh out” the definitions
and approach
• Start with site metrics, move to product
metrics later
>9,000 reportable sites (by FEI #)
>100,000 reportable product (by Application #)
April 16th 2014 ISPE
announces Pilot Program
• Partner with McKinsey for operational support
• Confidentiality of data
• Allow blinded comparison with industry ‘average’ and
technology platform peers
• Responsive to FDA’s recommendation for industry to
initiate activities
Quality Metrics Industry Pilot
6
Primary Objectives for the Pilot’s Initial
Phase
• Test a set of quality performance metrics based on
industry and FDA input to date
• Harmonize a set of metric definitions
• Test feasibility of data collection across different
companies
• Explore industry practices in quality culture and use
of process capability
• Inform continued industry input to the FDA
7
Input from Industry and FDA (Brookings Meeting, May 2014)
http://www.brookings.edu/events/2014/05/01-measuring-pharmaceutical-quality, The Brookings
Institution
8
Technology Specific metrics
Quantitative metrics
Media fill (for sterile aseptic sites) failures B
Environmental monitoring (for sterile aseptic sites) B
Lot acceptance rate B
Complaints rate (total B and critical
Confirmed OOS rate B
US recall events (total and by class) B
Stability Failure rate B
Invalidated (unconfirmed) OOS rate B
Right first time (Rework / Reprocessing) rate B
APQR reviews completed on time
Recurring deviations rate
CAPA effectiveness rate
Additional survey-based metrics
Process capability
Quality culture
M E A S U R I N G Q U A L I T Y P E R F O R M A N C E
Quality Metrics Industry Pilot Consensus Industry Metrics
B - metric proposed in Brookings meeting - Product- and site-based metric Metric set represents both leading and lagging indicators
Rationale for Choice of Metrics
• Quantitative metrics represent a balance:
• both leading and lagging indicators,
• measures of site, product and quality system performance
• Specific metrics for high risk operation – aseptic
filling
• Survey quality culture and process capability
• Culture obviously important, measurement not easy
• Process capability useful for identifying continual
improvement opportunities. No consistent view on
measures (CpK, PpK, etc).
10
June 2nd
ISPE-FDA
CGMP
Conference
Workshop
to explain
and launch
pilot
approach
Formal
check-in
with FDA
Timeline – Quality Metrics Industry Pilot
Pilot: Wave 1
▪ Confirm pilot participants
▪ Launch data collection
▪ Complete data collection,
clean/validate data
▪ Share initial findings and
correlations
▪ Individual report-outs to all
pilot participants
▪ Issue ISPE report on Wave 1
▪ Plan for Wave 2
June 2014 - Mar. 2015 2015+
Potenial
Wave 2
▪ Participate in Brookings
meeting to discuss FDA
direction
▪ Finalize metrics and
definitions
▪ Prepare data collection
templates and surveys
▪ Outline analysis
methodology
▪ Announce pilot details
Finalize metrics
and timelines
April-June 2014
11
Current Status – Quality Metrics Industry
Pilot
• 16 companies confirmed participation in Wave 1
• 38 sites
• Good spread of:
Technologies
Businesses
Regions
• Process established to gather input from participants
• Continuing informal interactions with FDA
• Regular updates on ISPE web site
12
Overview of the Sample: 38 Participating
Sites/Technologies1
15
7 5
3
8
API Bio DS Other Sterile Solids
17
9 10
3
Contract Cons. health
Gx Rx
19
12
3 4
NA Asia LA EMEA
By technology By business model
By region By company size
4
Small Large
34
1 If a site has more than 1 technology we count the number of separate templates they will fill, usually 1 per technology
• Influence the output from the Pilot program (choice of
metrics, definitions, data collection) based on actual
experience
• Have a blinded comparison to the overall industry
average and among technology platform peers
• Gain a head-start on enhancing internal procedures for
metric collection along with a set of metric definitions
• Develop insight into implications for metric
implementation
• Facilitate change management dialogue with internal
stakeholders
Quality Metrics Industry Pilot BENEFITS OF PARTICIPATING
14
• Sub teams continue to work on Quality
Culture Index and Process Capability
• Readout to Wave 1 participants 1Q 2015
• Input from participants to ISPE Report
• Discuss with FDA
• ISPE Report in 1Q 2015
• Inform Wave 2
15
Wave 1 of Pilot Program
Next Steps
Next Steps
• Continue to expand participation
• Assess a potentially adjusted metric set based on
learnings from Wave 1 and aligned with FDA
technical regulatory agenda
• Incorporate input from sub-teams working on
Quality Culture and Process Capability
• More focus on current data collection and analysis
• Continue to expand cooperation with other groups
and associations
Wave 2 of Pilot Program
16
In Summary – Quality Metrics Industry
Pilot
• Still enrolling for Wave 1
• Valuable insights already being
gained
• Excellent support and interest
from industry
• Ongoing dialogue with FDA and
other groups
• Follow us on the ISPE web site
• Send queries to
17
ISPE QUALITY METRICS CORE TEAM
MEMBERS
• Diane Hagerty (Team Leader) and Matt Pearson, Genentech/Roche
• Laura Cannon and Lorraine McClain, Teva Pharmaceuticals
• Michael Davidson, Pfizer
• Mairead Goetz and Lorraine Thompson, Novartis
• Peggy Speight, Bristol Myers Squibb
• Nuala Calnan, Dublin Institute of Technology
• Reem Malki, Mylan
• Paul Weninger, Perrigo
• Katy George, Vanya Telpis, Lorenzo Positano, Paul Rutten, McKinsey
• Chris Potter, ISPE Advisor
• Mary Storch, ISPE Regulatory Director