Implementing FDA requested Quality Metrics

ISPE Nordic Affiliate Event 26.Nov.2015Anne Sofie ØsterdalPrincipal Specialist

• What is FDA’s Quality Metrics initiative?

• Novo Nordisk’s approach to the guidance

• What we have done to prepare for the Quality Metrics initiative

• How we will influence the final guidance

• How we will be prepare to deliver

from the initial phase in 2013 to the current process of influencing the final FDA guidance on Quality Metrics

What is it all about?

Metrics calculated by the FDA• Lot Acceptance Rate• Product Quality Complaint Rate• Invalidated Out-of-Specification (OOS) Rate• Annual Product Review (APR) Timeliness

Optional reported metrics• Senior Management APR sign off• Training effectiveness• Process capability practice

Reporting scope• Annual reporting• Quarterly data• For API and FP• By product and site

3

Two tasks required anchored in QMS:• FDA expects internal use of

the FDA defined metrics• FDA requires data elements

submitted to FDA

• To conduct risk-based inspection

• To improve ability to predict and mitigate drug shortages

• To push industry towards more proactive quality management

• To further develop FDA compliance and inspection policies/practices.

4

Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA)

• We support FDA’s intentions with the guideline:• It as an opportunity to show good quality performance• It is a natural part of “QA oversight”• We will benefit from using the metrics in an internal monitoring programme

• We support to develop and deliver:• Both mandatory and optional metrics • Both internal monitoring programme and reporting to FDA

• We influence our position via ISPE, PhRMA, BIO and PDA

• All metrics will be applied in Novo Nordisk in 2016• Part of internal quality performance monitoring programme• Part of Quality Management Review

5

Novo Nordisk and Quality Metrics2013-2014

6

The first implementation of

Quality Metrics

• FDA will move to mandatory company reporting of quality metrics• Metrics should be presented by site and product

• The following 10 KPIs were identified:

Key take aways from the PDA conference Dec 9-10 2013

7

First step –more iterations followed during 2014

• Acknowledged the good intensions in FDA’s potential metrics

• Revisited our quality performance measures and decided to map metrics to our Quality Mission and our Quality Management System elements

• Implemented new, standardised measures per Site:• “Lot acceptance rate”• “Confirmed OOS rate”• “Timeliness of APR”• “Cpk value”

• Defined in total 16 metrics related to the Quality Mission and QMS• Implemented in senior management QMR reporting

• Ensured alignment of the metrics in terms of definition and standardised data collection across all sites and management levels

8

The new reporting setup aligned with the QMR agenda-

9

Lagging KPIs

Leading KPIs

Quality Metrics SAG 17 Dec 2014 10

Status 2013

New metrics based on expected FDA request

Well known internal metrics

New metrics based on internal request to measure QMS

11

• Novo Nordisk participated in the first ISPE pilot on Quality Metrics with 1 Site (Hillerød in DK)

• The site showed good performance compared to pears

• No surprises in the results

Learnings:• The pilot helped to illustrate the complexity in interpreting “Quality

Metrics definitions” and collection of data• We acknowledged the need for initiating an internal quality metrics

programme to be prepared for the FDA final guideline.

Presentation title Date 12

Reaction to launch of the FDA draft guidance

“Request for Quality Metrics”Novo Nordisk and Quality Metrics

August – November 2015

13

What we want FDA to consider by commenting on the draft guidance

1. Very complex data collection implying a significant resource burden

2. Clarification of all metric definitions is needed, as they can be interpreted in different ways

1. Start with a pilot to learn how quality metrics data can benefit FDA and the industry

2. Novo Nordisk has suggested changes or clarifications to all mandatory metrics. These are incorporated in comments from BIO, ISPE, PhRMA and PDA.

14

Challenges Recommendations

• Support data reporting per product, divided by site• Clarification is needed on how a “product” should be defined:

• One product can be approved in many variations (strength, type of device, content variations, country variations)

• Reporting separately for all variations of a product gives a significant increase in “product templates”. From 1 product template to 500 templates if all variations are reported separately

• Resource burden is highly underestimated: A major task to ensure traceability and data integrity in the entire data chain

• Comprehensive work to incorporate metrics data delivery in agreements with CMOs

• Support to start with a voluntary pilot phase if inspection readiness is evaluated from the beginning (incentives to participate is necessary)

15

• FDA quality metrics data collection for all products and all sites

• Extract data from source systems in Excel format

• Load data into a simple and flexible database

• Build “pilot” reporting for QMR 2015 data in Excel

• Adjust, if needed, when final guidance is launched

Scope for FDA reporting Not in scope for FDA reporting

Site Cl Site Ch Site BASite MOC

Source systems

Standard

STJSite Hi Site Ha

QMR, QPM, FDA reporting

• Develop robust and standardised reporting system (inspection ready)

• Set up governance for management approval of reporting to FDA

Building standard solution in 2016 (final guidance)Pilot in 2015/H1 2016

16

Quality Metrics SAG 17 Dec 2014 17

Status 2013

18

Acknowledgements, a special thanks to:• Lars Guldbæk Karlsen, Senior Vice President in PS Quality• Birgitte Holst, GMP and External Affairs Expert• Kristina Pieper Moe, Senior Project Manager

Questions?

Presentation title Date 19

!