QUALITY MANAGEMENT MATURITY

QUALITY MANAGEMENT MATURITY BY USFDA Kiran Kota

Quality management maturity (QMM) is the state attained when drug manufacturers have consistent, reliable and robust business processes to achieve quality objectives and promote continual improvement.

Regulatory Reference Document: White paper on Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals which has been released in April 2022

Relationship between Quality Metrics and Quality Management Maturity

Pharmaceutical WORK FORCE
QMM CHANGE MANAGEMENT BUSINESS CONTINUITY PLAN
ICH Q10
Quality System PROCESS PERFORMANCE PHARMACEUTICAL MANAGEMENT & QUALITY
SYSTEM & MANUFACTURING QMS, PERFORMANCE
RISK MANAGEMENT
cGMP & PRODUCT QUALITY QUALITY SYSTEM MANAGEMENT / CI
CAPA MANAGEMENT PROCESS PERFORMANCE SUPPLY CHAIN
MONITORING SYSTEM EFFECTIVENESS QUALITY CULTURE & QM
Quality Metrics SYSTEM MANAGEMENT REVIEW

KIRAN KOTA
QUALITY
Quality PHARMACEUTICAL QUALITY MANAGEMENT
Management QUALITY SYSTEM METRICS (QM) MATURITY
Maturity
QUALITY POLICY, MANUFACTURING STRATEGY
MANAGEMENT REVIEW & QUALITY CONTROL MANAGEMENT REVIEW
QUALITY OBJECTIVES, SUPPLY CHAIN & OPERATIONS SAFETY ENVIRONMENT
RESPONSIBIITY LABORATORY
AUDITS & COMPLIANCE ROBUSTNESS PRODUCTIVE ANALYSIS & REGULATORY COMPLAINCE &
QUALITY RISK PERFORMANCE
INCIDENT REPORTING & CUSTOMER FEED BACK PRODUCTION OPTIMIZATION
MANAGEMENT
DOC CONTROL & CI

Key Elements of Quality Management Maturity concept Focus Areas of Quality Management Maturity

QMM implementation on product life cycle concepts It is an umbrella concept and effective use of Quality Metrics
Management should set the tone of committment of Quality & and should Invest on employees
is one characteristic of robust QMM
QUALITY MANAGEMENT MATURITY

defined in ICH Q10

Organizational objectives should design to drive Quality to meet the QMM

cGMP inspections assessment is requied internally to have
(QMM) KEY ELEMENTS

QMM is a broad spetrum with the involvement of 21CFR

part 210 & 211 and ICH Q7 compliance on statutory & regulatory requirements
Quality system should be established in such a way that it shapes the Quality Culture in the organization

FDA has introduced this QMM to have effective FDA focus on each manufacturer being proactive than
measurement of Quality Metric reactive Always should focus on innovations & continual improvements towards Quality & regulatory compliance

Firm should move towards performance based Quality management system like proactive than reactive QMS
QMM assessments include on-site assessments based on
QMM is on site / establishment level remote review of QM & other voluntary submited data

Robust Quality Metrics program should be inculcated with the focus on data analytics

Identification of high risk sites through the assessment Quality defects assessment through FAR's & BPDR's
Quality Risk Management Plans and forecaseting to ensure reliability of generated data & product & supplies

Elements to be considered for an effective scoring of Quality Metrics Quality Management Maturity Umbrella

Lot Equipme Audit &

Process OEE nt Break Complianc
Acceptan
Capability ce Rate downs e

QUALITY MANAGEMENT MATURITY

Change
Manufactu Analysis Analysis
in
ring RFT RFT Lead time
Recalls
Products QUALITY METRICS Employee Ownership & Engagement

Business Continuity Plan Supply Chain

Lot Management Review & Responsibility
CAPA Calibratio
Release Invalidated Human Sustainable Compliance
effective n Time Enhanced PQS
Safety Environment
Cycle ness - OOS Error
lines Regulatory Compliance
time
Quality Culture

Manufacturing Strategy & operations Production Optimization

Repeat Ineffective Supply
deviation Control of Instrume
PQCR chain nt
rate Change Lead time Utilization

FDA Auditor expectations from the Industry on QMM during their inspections Failure levels & designation by USFDA Potential Challenges to the Firms on this QMM

Inspectors perspective on QMM during FDA inspection: Potential Challenges to align the QMM :
How Quality Metrics is being measured, evaluated & communicated throughout the organization.
Critical • Limits to FDA’s authority as a specific requirement at present.
QMM is more than just an awareness creation campaign on the Quality scoring at the site. • Burden to manufacturers to follow and submit the actuals.
Quality Metrics should be meaningful and fall within the Quality system.
Transparency should be encouraged for Quality related issues / events / failures. Major • Quality is considered as a department not as a responsibility.
Management should be aware of Quality related issues • Industry is still not understood or not fully interested to measure the
Quality Metrics rating scale will be decided based on the data submitted and witnessed thereafter at the site based on the
same Minor Quality Metrics.
• Low QMM rating is directly proportionate to Low Quality product /
Why USFDA collect data of Quality Metrics – an inspector perspective: 3 Failure levels: Culture.
New inspection protocol project (NIPP) has been established to develop standardized electronic inspection protocols for Level-1: Acceptable • No formal process of continual improvement.
three main tasks: Level-2 & 3: exceeding basic compliance • Quality Risk Management is merely a document exercise in the industry
Collecting the data of Quality Metrics to identify the high risk sites based on algorithm identification and same shall
gather during inspection in a structured manner to witness the submitted. With the designations as Critical, Major & as the actuals are not captured or assessed appropriately.
Reducing the variability in the inspectional findings among investigations. Minor based on the findings during the QM • Quality is independent from production merely on the document not in
Facilitating more efficient analysis of findings and sensitivity of the same.
review. functional in many organizations.

CONCLUSION ON QMM
1) U.S. FDA aims to ensure that drug manufacturers have consistent, dependable, and robust business processes to achieve their quality objectives and and promote continual improvement through this QMM concept.
2) QMM ratings will inform the FDA about quality management procedures at sites. It will also provide insight into factors that might result in a disruption to manufacturing and drug supply.
3) Pharmaceutical manufacturers will stand to make gains in efficiencies and regulatory flexibilities, and companies will be assisted in selecting contract manufacturing facilities.
4) Quality Management Maturity is effectively implementing ICH Q10 and moving quality management to a high maturity level by collecting meaningful data, predictive analysis, statistics, process capabilities and other tools to
prevent quality issues, supply disruptions and drug shortages.
5) The Quality Management Maturity Grid describes 5 maturity levels through which an organization or business will go through: Uncertainty, Awakening, Enlightenment, Wisdom & Certainty
6) The QMM is used by a business or organization as a benchmark of how mature their processes are, and how well they are embedded in their culture, with respect to service or product quality management.
7) USFDA is trying to identify the high risk sites based on the algorithmic identification.
8) 29 elements will be covered by FDA inspectors on 6system for surveillance audits and 24 elements or he pre-approval inspections such as facility, equipment, personnel, processes, analytical, management of supplies &
contractors, DI, QC, Process development program on Maturity and life cycle risk management.
9) QM should be meaningful trending data includes visuals on the flow indicating the performance status
10) Continuous monitoring mechanism to be established for RM-incoming materials, In-process, FP.
11) Monitor the equipment process parameters & failures.
12) Conduct robust and meaningful Internal audits
13) Utilize the principles outlined in ICH Q9 & QRM
14) Effective use of QM supports to QMM like PQS effectiveness through QM, Manufacturring Process performance, Laboratory performance & Supply chain assurance
15) QMM intension is to have proactive Quality system than the reactive Quality assessment.
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