Professional Documents
Culture Documents
Training
Modules
on
Water for Pharmaceutical Use
Good Manufacturing Practice
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WHO - EDM
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sterile products
non-sterile products
liquid products
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subject to:
planned maintenance
validation
monitoring
Annex 1, 17.32
Maintenance work should be documented
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Designed
2.
Constructed
3.
Maintained
4.
5.
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2.
3.
Validation
4.
5.
Records of testing
6.
7.
Schedules of maintenance
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2.
3.
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couplings
instrumentation
pipe slopes
flow rates
velocities
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2.
3.
System changes
4.
5.
6.
Validation studies
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2.
Sampling instructions
3.
Test procedures
4.
Responsible persons
5.
Training requirements
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Phase 1:
2 4 weeks
Phase 2:
4 weeks
Phase 3:
1 year
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DQ, IQ and OQ
Develop
operational parameters
cleaning and sanitization procedures and
frequencies
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PQ
Weekly sampling
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Weld quality
Hygienic couplings
Passivation
Air breaks or Tundish
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By-pass lines
By-pass valve
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2.
Temperature-compensated conductivity
meters
3.
4.
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2.
3.
4.
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1.
2.
3.
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IN C O R R E C T W A T E R T R E A T M E N T PL A N T
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M O D IF IE D W A T E R T R E A T M E N T PL A N T
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