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Advancing Pharmaceutical Quality:: Quality Management Maturity Program

This document provides an overview of the ISPE Advancing Pharmaceutical Quality (APQ) program. The APQ program aims to advance pharmaceutical quality through a maturity assessment, key performance indicators, and continual improvement tools based on the ICH Q10 framework. The goals are to support industry improvement, increase reliable product supply for patients, and provide regulators insight into industry quality focus areas. The APQ framework incorporates assessments, benchmarking, and operational/cultural excellence. Guides will provide details on conducting assessments, setting improvement programs, and example applications. The overall goal is a more efficient pharmaceutical industry reliably producing high-quality medicines with less regulatory oversight.

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Jc Naveen
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503 views14 pages

Advancing Pharmaceutical Quality:: Quality Management Maturity Program

This document provides an overview of the ISPE Advancing Pharmaceutical Quality (APQ) program. The APQ program aims to advance pharmaceutical quality through a maturity assessment, key performance indicators, and continual improvement tools based on the ICH Q10 framework. The goals are to support industry improvement, increase reliable product supply for patients, and provide regulators insight into industry quality focus areas. The APQ framework incorporates assessments, benchmarking, and operational/cultural excellence. Guides will provide details on conducting assessments, setting improvement programs, and example applications. The overall goal is a more efficient pharmaceutical industry reliably producing high-quality medicines with less regulatory oversight.

Uploaded by

Jc Naveen
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Advancing Pharmaceutical Quality:

Quality Management Maturity Program

Tami Frederick
ISPE Chair, APQ Committee
Senior Director, Corporate Quality Systems
and Cultural Excellence, Perrigo
State of Quality in the Pharmaceutical Industry
FDA 21st century vision for manufacturing and quality with input from academia and industry. The
desired state was described as follows:

“A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces
high-quality drug products without extensive regulatory oversight.”

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

Food and Drug Administration [Docket No. FDA-2018-N-1903] Modernizing Pharmaceutical


Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback
Program, June 2018

Connecting Pharmaceutical Knowledge ISPE.org


ISPE Advancing Pharmaceutical Quality (APQ)
Program Overview
 An industry-led program for advancing the state of Pharmaceutical Quality that
companies could leverage to achieve the goal of ensuring a continuous supply of quality
medicines to patients
 Built on the ICH Q10 framework enhanced to include operational excellence and quality
culture
 Deliverables are Guides to include maturity assessments, KPIs,
and continual improvement tools focused on the ICH Q10
elements Operational Excellence

 Complementary, where possible, to current regulatory


initiatives promoting quality excellence e.g.
PIC/S Data Integrity Guidance, FDA New Inspection Protocol
Project (NIPP), and the MHRA Data Integrity Guideline.

Quality Culture
Connecting Pharmaceutical Knowledge ISPE.org 3
Primary Goals of APQ Program
 Industry
 Supports and incentivizes sustained, continual improvement of a firm’s PQS
 Benchmarking & best practice sharing to accelerate progress

 Patients and Consumers


 Increased reliability of supply of quality product

 Health Agencies
 Better insight into industry’s focus and current expectations regarding critical quality areas
for advancing pharma quality

Connecting Pharmaceutical Knowledge ISPE.org 4


The ISPE Quality Metrics/Advancing Pharmaceutical
Quality (APQ) Timeline

2020

Connecting Pharmaceutical Knowledge ISPE.org


APQ Program Framework Based upon ICH Q10
 Quality Management Maturity Program: maturity assessment, KPIs, and improvement tools
 Assess, Aspire, Act, Advance
 Incorporated Pre- and Post-Benchmark Assessment for targeted improvement focus
 Piloted concepts with interested companies to validate and understand value to industry.
 Leverage Operational Excellence and Cultural Excellence as Foundation

Connecting Pharmaceutical Knowledge ISPE.org


ISPE Advancing Pharmaceutical Quality Program

Connecting Pharmaceutical Knowledge ISPE.org


7
ISPE APQ Guide Series - Content
Each of the 4 Modules of the Guide Series will contain:
 Background of the APQ Framework
 Overview and Structure of the APQ Framework
 How to conduct the Quantitative Pre- and Post-Assessments
• In the St Gallen Benchmarking program
OR
• By conducting internally
 How to conduct and score a deep dive Assess and Aspire exercise for each Q10
element
 How to set up an Act and Advance improvement program
 A worked example to assist practitioners

Connecting Pharmaceutical Knowledge ISPE.org


CAPA Maturity Assessment

Connecting Pharmaceutical Knowledge ISPE.org


CAPA Maturity Assessment

Connecting Pharmaceutical Knowledge ISPE.org


CAPA Program Tool Catalogue

Connecting Pharmaceutical Knowledge ISPE.org


ISPE Cultural Excellence Support Materials

Connecting Pharmaceutical Knowledge ISPE.org


APQ Guide Reviews

Industry Review & Pilot

Academia Review

Health Authority Review

Connecting Pharmaceutical Knowledge ISPE.org


ISPE Advancing Pharmaceutical Quality
Core Team Members
Tami Frederick APQ Chair, Perrigo Harry Jeffreys Bausch Health
Erika Ballman Perrigo Robert Kozak Mylan
Nuala Culnan Biopharm Excel LTD Matt Pearson Genentech
Lori Chelemedos Consultant, Pac Side LLC Jennifer Peszek Pfizer
Andrew Denny Bristol Meyers Squibb Chris Potter ISPE
Joseph Famulare Genentech Christine Teipen-Smith Eli Lilly
Kira Ford Eli Lilly Nelson Webb Proctor and Gamble
Betsy Fritschel Johnson and Johnson Carol Winfield ISPE
Steve Greer Genesis Assist Bryan Winship Jubilant Cadista
Michael Grischeau Abbvie Christian Woelbeling Koerber-Pharma

Connecting Pharmaceutical Knowledge ISPE.org

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