The document discusses quality metrics that are used in the pharmaceutical industry to monitor quality control systems and processes. It defines three key quality metrics that the FDA intends to calculate: (1) Lot Acceptance Rate (LAR), which measures the number of accepted lots versus total lots started; (2) Invalidated Out-of-Specification Rate (IOOSR), which measures invalidated out-of-specification test results versus total out-of-specification results; and (3) Product Quality Complaint Rate (PQCR), which measures the number of quality complaints received versus total units distributed. Quality metrics are important to ensure acceptable product quality and assess performance and improvements.

1. Presentation
On
Quality Metrics
By
Machhi Dhruvi Anilkumar
From
1st sem M. Pharm
(P’ceutical Quality Assurance)
Course name & Code:
Quality Management System
MQA102T
Smt. B. N. B. Swaminarayan Pharmacy Colleg, salvav-vapi
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2. CONTENTS :-
1. Introduction
2. Quality metrics
3. Need of quality metrics
4. Importance of Quality metrics
5. Lot Acceptance Rate
6. Invalidated Out-of-Specification
7. Product Quality Complaint Rate
8. Reference
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3. INTRODUCTION:-
In order to improve any system we need to monitor & measure &
In order to monitor & measure we need to establish metrics.
Metrics:-
It is defined as a system or standard of measurement
It is the assessment tool using figures or statistics to evaluate the
performance
Quality metrics:-
It is a particular system or standard to measure quality.
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4. QUALITY METRICS:-
Quality metrics are widely used throughout the Pharmaceutical industry to
monitor quality control systems and processes.
Quality metrics are a key component of an effective quality management
plan
They are the measurements used in ensuring customers receive acceptable
products or deliverables.
Quality metrics are used to directly translate customer needs into
acceptable performance measures in both products and processes.
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5. WHY ARE QUALITY METRICS IMPORTANT?
• The Pharmaceutical Quality System (PQS), a management system to
direct & control a pharmaceutical company with regard to quality
provides key elements of assurance oversee pharmaceutical
manufacturing and quality control laboratory processes throughout the
entire product lifecycle, from development through commercial
manufacturing.
• It ensures that quality drugs are available when patients need them.
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6. NEED OF QUALITY METRICS :-
Quality metrics are better tool to assess performance &
improvements
To improve product quality & development of team productivity
Responsibilities for setting up the measurement of what is
actually taking place with respect to quality.
Responsibilities for reviewing results against goals & for taking
action on significant variation.
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7. QUALITY METRICS THAT FDA INTENDS TO CALCULATE
1.LAR (Lot Acceptance Rate)
2.IOOSR (Invalidated Out-of-Specification Rate)
3.PQCR (Product Quality Complaint Rate)
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8. 1. LOT ACCEPTANCE RATE
(LAR)
The FDA defines Lot Acceptance Rate as,
“the number of accepted lots in a timeframe divided by the number of lots
started by the same covered establishment in the current reporting time frame”
no. of accepted lots in a timeframe
no. of lots started by the same covered
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LAR=

9. Ex:- Paracetamol
Time frame – Quarterly ( jan to march)
Tot. No. Of batches started for mfg in time frame – 100
No. Of accepted batches – 95
So, LAR = 95/100 = 0.95
LAR should be always equal to 1, or else proper justification should be
provided by production & QC
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10. 2. INVALIDATED OUT-OF-
SPECIFICATION RATE (IOOSR)
FDA defines Invalidated Out-of- Specification Rate as,
“the number of OOS test results for the lot released and long-term stability
testing invalidated by the covered establishment due to an aberration of the
measurement process divided by the total number of lots released and long-
term stability OOS test results in the current reporting time frame”
No. Of OOS test results for batch release & long term stability
testing invalidated by time frame
Tot. No. Of batch released & long term stability OOS test results
reporting time frame
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IOOSR=

11. Ex:- Paracetamol
Time frame – Quarterly ( jan to march)
Tot. No. Of batches started for mfg in time frame – 100
No. Of confirmed OOS ( Batch release + long term) =4
No. of tot. invalidations ( Batch release + long term) =5
So, IOOSR= 5/4 = 1.25
IOOSR should be always equal to zero (0) , otherwise proper justification
should be provided by QC / quality department.
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12. 3. PRODUCT QUALITY COMPLAINT
RATE (PQCR)
FDA defines PQCR as,
“number of product quality complaints received for the product
divided by the total number of dosage units distributed in the
current reporting timeframe”.
No. of quality complaints received for product
Tot. no. of dosage unit distributed in reporting timeframe
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PQCR=

13. Ex:- Paracetamol
Time frame – Quarterly ( jan to march)
Tot. No. Of Quality related complaints received in time frame – 2
Tot. No. of dosage units distributed in the current reporting timeframe -
1800
So, PQCR = 2/1800 = 0.001
PQCR should be always equal to zero (0), otherwise proper justification
should be provided by QA.
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14. REFERENCE :-
1. Submission Of Quality Metrics Data Guidance For Industry, U.S.
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research (CDER) ,Center for Biologics
Evaluation and Research (CBER), November 2016.
( https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/submission-quality-metrics-data-guidance-industry )
2. Quality metrics for drug manufacturing (21/1/’19)
( https://www.fda.gov/drugs/pharmaceutical-quality-resources/quality-
metrics-drug-manufacturing )
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15. THANK YOU
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