These presentations are compiled by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM, WHO and similar organizations.
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Quality risk managment basic facilitation methods
1. Quality Risk Management
Basic
Risk Management Facilitation
Methods
Presentation complied by Drug Regulations – a not for
profit organization from publicly available material
form FDA , EDQM . WHO and similar organizations.
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Pharmaceuticals.
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2. Flowchart
Check Sheets
Process mapping
Cause and Effect Diagrams (Ishikawa / fish bone)
They might be helpful to support risk identification
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3. Flowcharts
Start
Activity
Pictorial
Activity
representations
of a process
Decision No Action
Yes Breaking the process
Result down into its
constituent steps
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4. Check sheets
Present information
in an efficient, clear
format
May be accomplished
with a simple listing of
items
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5. Process mapping
The indicators may be selected based on unit
operations
Shows how they are interrelated
Potential Areas of Use(s) / outcomes
Provides a clear and simple visual representation
of involved steps
Facilitates understanding, explaining and
systematically analyzing complex processes and
associated risks
A pre-requisite for the use of some other tools
ICH Q9
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6. Ai
Dispensing
r
Scale Sieving Fluidized
Bed Dryer
Granulation Air
Process Magnesium
Stearate
Blendin
g
mapping Sieving
Tabletting
Packagin
g
Coating
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7. Cause and Effect Diagrams (Ishikawa / fish bone)
Environment People Materials
Problem
statement
Equipment Measurement Methods
System
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8. Cause and Effect Diagrams (Ishikawa / fish bone)
To associate multiple possible causes with a single effect
Constructed to identify and organize possible causes for it
Primary branch: represents the effect
Major branch: corresponds to a major cause
Minor branch: correspond to more detailed causal
factors
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9. Cause and Effect Diagrams (Ishikawa / fish bone)
How to perform?
Define and agree a precise problem statement
(put as “head” of fish bone) Think “What could be
its causes?” for each node
Add it to the “fish bone” diagram
For each line pursue back to its root cause
Consider splitting up overcrowded sections
“bones”
Consider which potential root
causes and the need for
Environment People Materials
further investigation on them Problem
statement
Equipment Measurement
System Methods
10. Cause and Effect Diagrams (Ishikawa / fish bone)
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11. Coating Drying Milling Analytical
Temperature
Spray Rate Redrying
Pan Speed Time Temp
Milling
Gun Distance RH Screen Size Other
Temperature Air Flow Porosity Sampling
Atomizing Air Pressure Shock Cycle Mill Speed Method
Tablet
Drug
Hardness
Operator Precompressing Water Substance
Temp/RH Main Compressing Binder Age
P.S.
Operator Feeder Speed Temp Process Conditions
LOD
Cause and
Training Press Speed Spray Rate
Punch Penetration
Spray Pattern
HPMC
Effect
Depth
Methoxyl
Tooling P.S.
Hydroxyl
Diagram
Plant Feed P.S.
Scrape Down
Factors Frame LOD
Compressing
Chopper Speed Other
for Tablet
Hardness
Mixer Speed Syloid
Lactose
Endpoint Raw
Coating
Materials
Power
Granulation
Time
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