Quality metrics in the pharmaceutical industry are essential for monitoring processes, assessing departmental performance, and driving continuous improvement. Key metrics include Lot Acceptance Rate (LAR), Invalidated Out-of-Specification Rate (IOOSR), and Product Quality Complaint Rate (PQCR), each providing specific insights into manufacturing, quality control, and quality assurance. These metrics aim to ensure compliance and highlight areas needing justification when targets are not met.

1. Quality Metrics
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2. Quality Metrics
• Quality metrics are used in the pharmaceutical industry to
monitor process, quality and drive continuous improvement.
• Quality metrics are helpful for Chairmen, MD, CEO & higher
management to evaluate & know the firm performance
(*Indirectly different department employees performance &
productivity).
• Quality metrics are better tool, especially to assess your
different departments (especially Mfg, QC & QA) performances
& improvements on timely (Monthly /Quarterly).
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3. Quality Metrics
• LAR – First indicator helpful for measure the
production & QC department performance
(Lot Acceptance Rate).
• IOOSR – Second indicator helpful for
measure the QC performance (Invalidated
Out-of-Specification Rate).
• PQCR – Third indicator helpful for measure
the QA department performance (Product
Quality Complaint Rate)
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4. Quality Metrics
 LAR = the number of accepted batches in a timeframe / the number of batches started by the same
covered in the current reporting timeframe.
• Example: Paracetamol
• Time frame – Quarterly (Jan to Mar)
• Total number of batches started for manufacturing in a time frame = 100
• Number of Accepted batches = 95
• Formula: LAR = 95/100 = 0.95
 (LAR should be always equal to 1, otherwise proper justification should be provided by production &
QC)
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5. Quality Metrics
 IOOSR = the number of OOS test results for batch release and LT stability testing invalidated by the time
frame / total number of batch release and LT stability OOS test results in the same reporting timeframe.
• Example: Paracetamol
• Time frame – Quarterly (Jan to Mar)
• Total number of batches started for manufacturing in a time frame = 100
• No of confirmed OOS (batch release + LT) = 4
• No of total Invalidations (batch release + LT) =5
• Formula: IOOSR = 5/4 = 1.25
 IOOSR should be always equal to 0 (zero), otherwise proper justification should be provided by QC
/Quality department.
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6. Quality Metrics
 PQCR = the number of product quality complaints received for the product / total number of
dosage units OR API batches distributed in the current reporting timeframe
• Example: Paracetamol
• Time frame – Quarterly (Jan to Mar)
• Total number of Quality related complaints received in a time frame = 02
• No of dosage units OR API lots distributed reporting time frame = 1800
• Formula: PQCR = 1/180000 = 0.001
 PQCR should be always equal to 0 (zero), otherwise justification should be provided by QA.
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Any Questions? / Any suggestions