Quality Measurements in Pharmaceutical

Industry

PIYUSHTRIPATHI

WHAT IS QUALITY ?

Expressed by the ISO definition:

"The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs".

Vision for 21st Century Manufacturing

“A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”

Are we there yet ?

CHALLENGES

•What about quality?

•What about flexibility?

•What about workload?

•What about focus?

WHAT IS QUALITY METRICS?

An objective measure of the quality of a product or process• Quality is the fitness for intended use of the product, relevant to patients• Product (and/or process) segmentation

An objective measure of the quality of a site• Quality is measure of site’s ability to manufacture products fit for intended use• Site segmentation (can include a build of product/process scores)

An objective measure of the effectiveness of systems associated with the manufacture of pharmaceutical products, including the pharmaceutical quality system

• On site evaluation of quality systems

Percent of CAPA completed within agreed time

• Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal and external processes.• Performance Metric is an essential element of the

management review process –

# Accountability # Alignment# Attention # Behavior# Expectations # Feedback# Motivation # Objectivity# Problem Solving # Visibility

ELEMENTS OF QUALITY METRICS

WHY USE QUALITY METRICS?

•Common language to measure progress around quality•Objective measures provide clarity to all•Potential useful to reduce shortages•Path to achieve regulatory flexibility and reduced post market change control burden

SOME POTENTIAL METRICS

•Batch Failure Rate

•Right First Time

•OOS / Laboratory Failure Investigation Rates

Requesting 10 baseline quality metrics by FDA -1. The number of lots attempted of the product.2. The number of specification-related rejected lots of the product, rejected

during or after manufacturing.3. The number of attempted lots pending disposition for more than 30 days.4. The number of OOS results for the product, including stability testing.5. The number of lot release and stability tests conducted for the product.6. The number of OOS results for lot release and stability tests for the product

which are invalidated due to lab error.7. The number of product quality complaints received for the product.8. The number of lots attempted which are released for distribution or for the

next stage of manufacturing the product.9. Whether the APRs or PQRs were performed within 30 days of the annual due

date.10. The number of APRs or PQRs required for the product.

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