review on qailty metrices

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
23/7/2016

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
33/7/2016

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.
53/7/2016

6. What about Quality?
What about flexibility?
What about focus?
What about workload?
63/7/2016

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.
73/7/2016

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.
83/7/2016

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
93/7/2016

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
103/7/2016

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
113/7/2016

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.
123/7/2016

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.
133/7/2016

14. 1. Accountability
2. Alignment.
3. Attention
4. Behaviors
5. Expectations
6. Feedback
7. Motivation
8. Problem Solving
9. Visibility
143/7/2016

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)
163/7/2016

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.
173/7/2016

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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19. 193/7/2016