Quality Metrics
Objectives
• Pharmaceutical Quality for the 21st Century
• Why Quality Metrics (QM)?
• Initial draft of the QM Guidance
• Key Features of the QM Revised Draft Guidance
• Phased-In Approach and Benefits to Participants
• How FDA Intends to Use Metrics Data
Pharmaceutical Quality for 21st Century Initiative
Vision
“A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high
quality drugs without extensive regulatory oversight.”
Desired State of Manufacturing
• Manufacturers have extensive knowledge about critical product and process parameters and quality
attributes
• Manufacturers strive for continuous improvement
• FDA role: Initial verification, subsequent audit
• Minimal manufacturing supplements needed for postapproval changes.
Existing Quality Metrics Programs
• Many manufacturing establishments currently use quality metrics as a part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment
• Current good manufacturing practice (CGMP) for human drugs requires manufacturers to have an ongoing program to maintain and evaluate product and process data that relate to product quality
• Continued process verification includes a Periodic Product Review
(PPR):
– conducted at least annually
– data collected includes relevant process trends and quality of incoming materials or components, in-process materials, and finished products
• Programs should be tailored to include those metrics that the manufacturer finds useful in performing these product- and establishment-specific evaluations
Robust Product/Site Measurement Program
Other Metrics Likely to be Useful
• Lot acceptance rate
• Invalidated and validated OOS rate
• Product quality complaint rate
• Deviations without assigned root cause
• Periodic Product Review Completion
• Right-First-Time• Quality culture
• Process performance and capability
• Senior management commitment to quality
• CAPA effectiveness (retraining,preventive actions)
• Reliability of drug availability
• Unplanned/planned equipment/facility maintenance rate
Quality Metrics Programs Indicators of Maturity
• Identifying existing problems vs. predictive analytics
• Importance of quality culture
• What are useful product- and site-specific metrics?
• How committed is senior management to overall quality?
• How committed is the entire staff to quality culture?
• Does the program improve over time?
Why Quality Metrics?
Industry
• Enables continual improvement of process performance and product quality
• Supports continual improvement of the pharmaceutical quality system
• Important element of oversight and controls over the manufacture of drugs to ensure quality (section
501 FD&C Act)
FDA
• Additional insight into the state of quality for product and facility
• More quantitative and objective measure of quality at the product, site, and system levels
• Enhance risk-based surveillance inspection scheduling model
• Improve effectiveness of inspections
• Help to identify factors leading to supply disruption
• Gain insights/trends regarding the state of quality across the pharmaceutical industry
Patients
• More reliable patient access to important therapies
– Commitment to ongoing improvement by industry leads to more robust manufacturing processes
– Fewer recalls
– Fewer quality-related drug shortages
Submission of Information is Voluntary
• During the voluntary phase of the reporting program,FDA does not intend to require the submission of this
information
• FDA does not intend to take enforcement action based on errors in a quality metrics data submission
made during this voluntary phase of the reporting program, provided the submission is made in good
faith
Voluntary vs. Mandatory
• Extent to which FDA can achieve its goals for the QM program will be largely driven by the extent of
participation
– Large body of data is needed to draw the most meaningful conclusions about the quality of a site or product
• Developed additional incentives for reporting
Benefits of Participation
• Opportunities for participants to provide feedback and additional comments, as well as share knowledge from
ongoing, industry-driven quality metrics programs
• FDA working informally with establishments towards early resolution of potential quality problems
• Improved inspection effectiveness (e.g., more focused inspections)
• Enhance premarket and postmarket review program (e.g. consider use of calculated metrics as an element of the postapproval manufacturing change reporting program)
• Reduction in inspection frequency
• Inclusion on the Quality Metrics Reporters List
Quality Metrics in the Short Term
Test and improve the electronic portal submission process
• Incentives for establishments going “above and beyond”– Additional opportunities for feedback from participating
establishments
– Quality Metric Reporters List
– Enhance pre-market and post-market review program
– Reduction in inspection frequency based on reporting
• Improve and mature the program based on feedback and
analytics
– Publish summary of initial reports
• Ensure program supports, not deters, emerging technology
Quality Metrics in the Short Term
Continuing discussions with external groups
– Measuring and assessing quality culture
– Ongoing improvement in definitions and examples
– Continuing discussions with a range of industry groups/representatives
• Non-application products
• Contract manufacturers
• Active ingredient manufacturers
– Evaluate additional sources of data to study quality metrics
Quality Metrics in the Long Term
• Predictive analytics
– Correlation with FDA data (e.g., inspection outcomes, recalls,FARs)
– Drug supply disruption
• Continue to recognize participating establishments
– Quality Metric Reporters List (?)
– Enhance premarket and postmarket review program (e.g., postmarketing change reporting program)
– Potential reduction in inspection frequency based on data
• Continue to encourage emerging technology
• Other incentives?
• Voluntary reporting alone may not be sufficient to accomplish FDA’s goals for the program
• Greater net benefit for FDA and industry likely to result from a fully operational program
– Incorporate initial learnings
– Fuller participation
• Continuing to plan for notice and comment rulemaking
Summary
• Quality Metrics play an important role in the desired state of pharmaceutical quality and regulation –
minimal but effective regulatory oversight that results in quality drugs available for patients
• Development of the FDA program is a journey that has reached an important next step
• In collaboration with participating industry stakeholders, we will incorporate learnings from this initial phase of the program to more fully realize the potential of quality metrics
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