"Quality Metrics" not only helpful US FDA, moreover helpful for all pharmaceutical industries. Quality metrics are helpful for Chairman, MD, CEO & higher management to evaluate & know the firm performance (*Indirectly different department employees performance & productivity).

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