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Tools for Assessing and Advancing Your Quality Systems’ Maturity

ISPE Advancing Pharmaceutical Quality Team
Tools for Assessing and Advancing Your Quality Systems’ Maturity

Advancing Pharmaceutical Quality continues to be a hot topic as industry sees the benefit in an industry-for-industry program to advance continual improvement. FDA is reflecting on the messages it is hearing in response to the 2018 Federal Register Notices, Modernizing Pharmaceutical Quality Systems and has embarked on a feedback period with initial output from some site visits potentially available for this session.

To meet FDA’s challenge to advance pharmaceutical quality, ISPE in conjunction with other associations and academia have established significant programs such as ISPE’s Advancing Pharmaceutical Quality program, and St Gallen University’s research on quality metrics sponsored by FDA.

On Wednesday, 30 October, at the 2019 ISPE Annual Meeting & Expo, industry and academic experts will provide latest information and future plans for:

  • Benefits of using a Quality Maturity Framework. CAPA and Management Responsibilities system as the first elements of an ICH Q10 Pharmaceutical Quality System to better understand one’s own quality maturity and aspire to improve.
  • Evaluating and improving quality culture using tools developed by a joint association team e.g. Root Cause Analysis and Human Error
  • Findings from St Gallen University Quality Metrics research for FDA, Year 3
Tami J. Frederick
Senior Director, Corporate Quality Systems & Cultural Excellence
Betsy P. Fritschel
Director, Regulatory Compliance
Johnson & Johnson
Thomas Friedli, PhD
Professor and Director
University of St.Gallen

An FDA representative has been invited to provide the latest information related to their Modernizing Pharmaceutical Systems programs such as:

  • Update on FDA’s Quality Metrics Feedback program of Type C meetings, pilot program and site visits
  • Progress of NIPP
  • Views on St Gallen’s research

Who Should Attend This Session?

The intended audience is individuals who have a role in development and implementation of pharmaceutical quality systems, operational excellence and quality culture, essentially anybody involved in manufacturing operations.

How Does This Topic Address the Conference Theme of Modernize, Globalize, Transform?

The title of FDA’s 2018 FRN, Modernizing Pharmaceutical Quality Systems says it all! The sentence

While much progress has been made, we have not fully realized our 21st century vision for manufacturing and quality.

speaks to the challenge and degree of transformation still required.

ISPE’s Advancing Pharmaceutical Quality program is being designed to have global applicability and link with ISPE’s global Pharma 4.0 program.

What Is a Quality Maturity Framework?

The ISPE Advancing Pharmaceutical Quality Core Team is developing an industry-led program designed to help industry advance pharmaceutical quality based on the ICH Q10 Pharmaceutical Quality System Model. There are three overall phases to the Advancing Pharmaceutical Quality (APQ) Program – assess, aspire, and advance. During assessment, a company would utilize a maturity assessment process designed around the ICH Q10 elements, to evaluate its level of quality maturity for each element. This maturity assessment would help a company to determine the current state as it relates to where a company “aspires” to be by element. The program also provides guidance on tools and key performance indicators that a company could utilize in order to “advance” or improve their quality maturity. Many companies and consultants have self-assessments and programs to assess maturity, however, there is no known assessment that directly aligns to ICH Q10 and applies to the entire pharmaceutical industry (e.g. API, drug product, etc.)

The main objective is, therefore, to provide guidance and tools for assessing and advancing the maturity of an organization’s quality systems.

This framework will bring value by providing a practical set of tools for assessing and improving the maturity of quality systems which in turn will bring value to their customers and business.

The first developed Q10 element is Corrective Action and Preventive Action (CAPA) with Management Responsibilities to follow.

Why Discuss Quality Culture?

Quality Culture has always been important within pharmaceutical manufacturing operations. Strong companies know this and have invested resources in systems and personnel to support and promote a focus on quality processes, product quality, and meeting patient needs. The importance of quality culture has been confirmed in results from ISPE Quality Metrics Pilot Studies and from St Gallen’s Year 2 research

More recently, health authorities have placed additional emphasis on quality culture by including it in guidance documents and inspection protocols like the PIC/S Data Integrity Guidance, FDA New Inspection Protocol Project (NIPP), and the MHRA Data Integrity Guideline.

Members of the ISPE and PDA culture task forces have come together to develop a Guide to Improving Quality Culture in Pharmaceutical Manufacturing Facilities that identifies specific aspects of quality systems and culture and recommendations for tools, techniques, and processes to assess and improve. The first published outputs are on Root Cause Analysis and Human Error.

In 2017, ISPE published the ISPE Cultural Excellence Report which shares the vision of quality culture improvements across six dimensions, utilizes a 19-behavior cultural maturity assessment, outlines a series of practices and tools to support implementation, and provides a practical frame of reference for companies that want to build healthy quality cultures within their organizations.

What Is Quality Metrics Research?

The FDA Quality Metrics initiative has emerged directly from the FDA Safety and Innovation Act (US Congress, 2012). It aims to ‘support the modernization of pharmaceutical manufacturing as part of the FDA’s mission to protect and promote public health’ (FDA, 2016), by encouraging both the industry and the regulators to implement modern, risk-based pharmaceutical quality assessment systems to enable them to understand the current state of quality across the global pharmaceutical manufacturing sector.

As part of this initiative, in 2016, the FDA awarded a research grant to the University of St.Gallen, Switzerland to help establish a scientific basis for relevant pharmaceutical manufacturing performance metrics, which may prove useful in assessing the current state of quality and in predicting risks of quality failures and/or drug shortages.

Results from the first year of this collaboration were published in a research report issued in October 2017. In July 2017, the grant was extended for a second year of further research with a report being issued in November 2018. The research has continued for a third year and preliminary results will be presented at this session.


With 6 extensive education tracks, 85+ hours of targeted technical sessions, 24+ hours of networking opportunities, 200+ exhibitors, Discovery Stage in Expo Hall, 2 days of in-depth classroom training & more, the 2019 ISPE Annual Meeting & Expo is an event you don’t want to miss! Take advantage of the registration discount that is available through 17 September and register today.