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Quality Metrics :

Quality Metrics 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 1 11/30/2015

Content :

Content What is quality matrices...? Why use of matrices……? How does industry use Metrics..? USFDA Challenges and Requirements Next Steps References 2 11/30/2015

Quality metrics :

Quality metrics 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 3 11/30/2015

Quality Metrics:

Quality M etrics 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. 4 11/30/2015

Why use of metrics…???:

Why use of metrics…??? T o 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. 5 11/30/2015

USFDA Challenges :

USFDA Challenges What about Quality? What about flexibility? What about focus? What about workload? 6 11/30/2015

USFDA Vision For The 21st Century:

USFDA Vision For T he 21st Century “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. 7 11/30/2015

Quality Metrics And Food And Drug Administration Safety And Innovation Act:

Quality Metrics A nd F ood A nd D rug A dministration S afety A nd I nnovation A ct 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 . 8 11/30/2015

How does industry use Metrics..? :

How does industry use Metrics..? 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 9 11/30/2015

FDA has published a list of Metrics of Potential Interest:

FDA has published a list of Metrics of Potential Interest Lot Acceptance Rate = 1- Right First Time Rate  =  1 –    10 11/30/2015

Continue…:

Continue… Product Quality Complaint Rate  = Invalidated Out-of-Specification (OOS) Rate= Annual Product Review (APR) on Time Rate =   11 11/30/2015

Continue …:

Continue … Corrective and Preventative Action (CAPA) Rate =     12 11/30/2015

Continue.. :

Continue.. 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. 13 11/30/2015

Key function of quality metrics:

Key function of quality metrics Accountability Alignment . Attention Behaviors Expectations Feedback Motivation Problem Solving Visibility 14 11/30/2015

Developing quality metrics:

Developing quality metrics 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 15 11/30/2015

Key Points For Quality Metrics:

Key Points F or Q uality M etrics Keep it simple Improve the objectivity Potential for regular flexibility Build consensus Promote the right behaviors ( design metrics carefully to avoid unintended consensus) 16 11/30/2015

Next Steps:

Next Steps 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( P ersonal  digital  assistant ) meeting . 17 11/30/2015

References :

References International conference of harmonization of technical requirement for registration of pharmaceutical for human use, ICH harmonization tripartite guideline pharmaceutical development-98, August 2009 Food and drug administration safety and innovation act July 9,2012. http :// www.drugregulations.org www.ispe.org   www.ich.org 18 11/30/2015

Thank you :

Thank you 19 11/30/2015

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