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Mr. Perete's Presentation - Validation PDF
Mr. Perete's Presentation - Validation PDF
Process Validation
From Design Space to Continuous Process Improvement
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AGENDA:
DAY 1
DAY 2
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CREDITS
• ISPE Guide Series: Product Quality LifeCycle Implementation (PQLI) from Concept to Continual
Improvement, Part 1 – Product Realization using Quality by design (QbD): Concepts and Principles.
International Society of Pharmaceutical Engineering (ISPE). First Ed., November 2011. www.ispe.org
• ISPE Guide Series: Product Quality LifeCycle Implementation (PQLI) from Concept to Continual
Improvement, Part 4– Process Perfomance and Product Quality Monitoring System. International Society
of Pharmaceutical Engineering (ISPE). First Ed., 2013. www.ispe.org
• Lepore, J. Expectations / Deliverables from PV Stage 1. ISPE Process Validation Conference, 2012.
Silverspring, MD.
• Johnson, Marc D. Statistically Determined Acceptance Criteria and Sampling Plans for PPQ. ISPE Process
Validation Conference, 2013. New Brunswick, NJ.
• Barrick, J. Process Validation Stage 2: Determining and Justifying the Number of Process PQ Batches .
ISPE Process Validation Conference, 2013. New Brunswick, NJ.
• Barrick, J. Continued Process Verification, PV Stage 3a Decisions. ISPE Process Validation Conference,
2013. New Brunswick, NJ.
• Kiefer, M. Challenges in Implementing the Life for Generic Manufacturing. ISPE Process Validation
Conference, 2013. New Brunswick, NJ.
CREDITS (cont...)
• Wee, C. Learnings for Quality by Design (QbD) from a Total Quality Management Perspective. ISPE
Annual Conference. 2014. Singapore
• Piriou, J. et al. Control Strategy as the Keystone of the Product LifeCycle, from Product/Process
Understanding to Continuous Process Verification and Improvement . Pharmaceutical Engineering; Vol. 32
No. 1: Jan/Feb 2012. www.ispe.org
• Perete, C. Process Optimization of Herbal Tablet Manufacturing using Central Composite Design.
University of the Philippines, 2007. Manila.
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PROCESS VALIDATION
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Product
Discontinuation
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Quality Risk
Management
Statistics
Process QTTP, CQA,
CPP, Design
Validation Space
Quality
Management
System
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PROCESS VALIDATION
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Process Validation:
from documentation to science . . .
US FDA 1987 PV Guideline US FDA 2011 PV Guideline
IQ, OQ, PQ prior to commercialization Covers process design , tech transfer and
commercial manufacture (product lifecycle)
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Product /
Target Product Process Continual
Prior Control
Product /Process Design Improvement
Knowledge Strategy
Profile Dev Space
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Granulation Bulk
solution (% Density
w/v) – X2
Particle
Size
Mixing
time (mins) Wet Distribution
– X1
Granulation Tablet
Weight –
Y3
Moisture
Content – Tablet Tablet
X3 Compression Friability–
Y2
Raw Disintegrati
material on Time –
QC Y1
DESIGN SPACE – the multidimensional combination of input variables and process parameters that
have been demonstrated to provide assurance of product quality. Mathematically expressed as
Y = f (aX1) + (bX2) + (cX3) + ...
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Y (Tablet Hardness) = 4.63 – 0.05 X1 – 0.15X12 – 0.07 X2 + 0.13 X22 + 0.05 X3 + 0.05 X32+
0.06 X1X2 – 0.35X1X3 + 0.15 X2X3
Where: X1= Mixing Time, X2= Moisture Content, X3= % Granulating Solution
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WORKSHOP No. 1:
2. Your group will be assigned to work on a particular dosage form, and you will 2 mins.
be issued with a corresponding QTTP
3. Develop a process flow diagram for your assigned product 10 mins.
4. Conduct a process FMEA using the severity, probability and detectability 40 mins.
scales discussed in the lecture
5. Identify the CRITICAL QUALITY ATTRIBUTES (CQA) 10 mins.
8. Assign personnel who will report the FMEA, CQA, CPP and Product Control 20 mins.
Strategy to the PLENARY
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WORKSHOP No. 2:
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2. Your group will be assigned to work on a particular dosage form, and you will be 2 mins.
issued with product in-process control data
5. Analyze your charts for any out of control (OOC) and out of trend (OOT) data 10 mins.
7. Re-visit your FMEA (from Workshop No. 1) and assess impact on the product 15 mins.
control strategy
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Thank you!
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