This presentation discusses quality metrics and how the pharmaceutical industry uses metrics. It defines quality metrics as elements that evaluate processes like customer satisfaction and defects. Metrics can help improve quality and productivity. The FDA requires metrics to evaluate manufacturing quality and reduce drug shortages. Guidelines like ICH Q8-Q11 provide a framework for using metrics flexibly to focus on quality. Leading and lagging metrics are discussed.

1. Presented by
Rasika .Walunj
M.Pharm (III SEM)
Guided by
Prof.S.V. Joshi
PE Society’s
Modern College Of Pharmacy (For Ladies),
Moshi, Pune . 412105 13/7/2016

2. 1. What is quality matrices...?
2. Why use of matrices……?
3. How does industry use Metrics..?
4. USFDA Challenges and Requirements
5. Next Steps
6. References
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3. Performance of metrics are an essential element of
the quality management review process.
Quality metrics may include elements such as
customer satisfaction, supplier performance,
manufacturing defects, complaints, cycle times
and many other internal or external processes.
This presentation provides a framework for
establishing right quality indicators for
evaluating the performance of the quality system
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4. • Definition in One sentence of quality metrics
explaining the Metric Per cent of Corrective
and Preventative Action (CAPA) Rate
(CAPA) completed within agreed time.
• Benefit of quality matrices is Quality
objective to be achieved.
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5. To improve product quality and development of team
productivity.
Potential useful to reduce shortages.
Responsibilities for setting up the measurement of
what is actually taking place with respect to quality.
Responsibilities for reviewing result against goals
and for taking action on significant variation.
Path to achieve regulatory flexibility and reduced
post market change control burden.
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6. What about Quality?
What about flexibility?
What about focus?
What about workload?
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7. • “A maximally efficient, agile, flexible
pharmaceutical manufacturing sector that
reliably produces high quality drugs without
extensive regulatory oversight”
• There have many guidelines issued by USFDA
and by the international conference on
harmonization(ICH)Q8,Q9,Q10,Q11which
have provide a regulation to move towards
desire state.
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8. In July 2015, the Food and Drug Administration
Safety and Innovation Act (FDASIA) was enacted.
This act requires the formation of a task force to
develop and implement a strategic plan for
enhancing the Agency's response to preventing
and mitigating drug shortages.
To assist in the evaluation of product
manufacturing quality, USFDA is exploring the
broader use of manufacturing quality metrics.
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9. Risk identification – systematic use of
information to identify potential sources of harm
(hazards) referring to the risk question or problem
description [ICH Q9 ]
Enables the detection of potential problems as
early as possible to plan corrective and preventive
actions
Important in achieving problem resolution and
problem prevention
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10. Lot Acceptance Rate =
1-
the number of lots rejected in a year
number of lots attempted in the same year
Right First Time Rate =
1 –
the number of lots with at least one deviation in a year
the number of lots attempted in the same year
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11.  Product Quality Complaint Rate =
The number of complaints received by the manufacturer of the product
the total number of lots released by the manufacturer of the product in the same year.
 Invalidated Out-of-Specification (OOS) Rate=
Number of OOS test result establishment in a year
Total number of tests performed by the establishment in the same year.
 Annual Product Review (APR) on Time Rate =
The number of APRS generated within 30 days of annual due date at the establishment
The number of products produced at the establishment
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12. • Corrective and Preventative Action (CAPA) Rate =
the number of corrective or preventative actions that were initiated due to an APR,
the total number of APRs generated.
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13. • Management Engagement – The most senior
manager that signed each annual product
review, reported as one of the following:
(1) None specified,
(2) Line quality manager,
(3) Site operations manager, or
(4) Corporate executive manager.
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14. 1. Accountability
2. Alignment.
3. Attention
4. Behaviors
5. Expectations
6. Feedback
7. Motivation
8. Problem Solving
9. Visibility
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15. • Good metrics system consists of leading and
lagging indicators.
• Lagging indicators measure the outcomes of
what already happened.
• Leading indicators provide information that
may be able to predict future outcomes.
• More mature organizations will typically have
a greater ratio of leading to lagging metrics
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16. Keep it simple
Improve the objectivity
Potential for regular flexibility
Build consensus
Promote the right behaviors ( design metrics
carefully to avoid unintended consensus)
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17. • FDA is currently evaluating feedback.
• Anticipate more information in Q2 of this year
• ISPE (International Society for Pharmaceutical
Engineering) participating in a pilot with FDA and
small subset of companies discussions to occur at
June ISPE/PDA(Personal digital assistant)
meeting.
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18. 1. International conference of harmonization of
technical requirement for registration of
pharmaceutical for human use, ICH harmonization
tripartite guideline pharmaceutical development-98,
August 2009
2. Food and drug administration safety and innovation
act July 9,2012.
3. http://www.drugregulations.org
4. www.ispe.org
5. www.ich.org
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