Professional Documents
Culture Documents
Personnel,
Premises and
Equipment
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Personnel
Objectives
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Personnel
Principle
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Personnel
General
Organization Chart
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Personnel
General
Motivated to
support the establishment
maintain high-quality standards
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Personnel
Key Personnel
Key personnel (which normally should be full-time)
positions include:
Head of Production
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Personnel
Training
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Personnel
Training
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Personnel
Visitors or Untrained Personnel
Preferable not to take them in. If this is unavoidable,
for example GMP inspectors:
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Premises
Objectives
1)
2)
3)
4)
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Premises
General Requirements
Premises must be located, designed, constructed, adapted
and maintained for the operations:
Premises must be located to minimize risks of crosscontamination; e.g. not located next to a malting factory
with high airborne levels of yeast
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Premises
General Requirements
Neighbours
What do they do?
What impact can they have on the business?
Pollution/effluent control
Facilitate sanitation.
Services availability
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Premises
General Requirements
Maintenance workshops
Animal houses
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Premises
Design Principles
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Process flow
Material flow
People flow
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Premises
Example of Materials and People Flow
Arrival of goods
Offices
Canteen
Gowning
Incoming
Flow
goods
Material
Corridor
Shipping
Corridor
Corridor
Raw
Clean
Materials
&
Packaging Weighing
Packaging
Storage
Zone:
Processing
Filling
Packaging Finished
Products
Storage
Controlled
Washing
Zone:
Zone:
Machine
Shop
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People Flow
Corridor
Waste Treatment
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Premises
Warehouse
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Premises
Weighing areas (Dispensing)
Segregation
Cleaning
Documentation
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Premises
General Requirements
Waste disposal
Proper control over segregation and disposal
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Premises
General Requirements
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Premises
General Requirements
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Premises
Manufacturing and Packaging
Drain design:
equipped to prevent backflow
open channels avoided
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Premises
Manufacturing and Packaging
Prevention of cross-contamination
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Premises
In-Process and QC laboratories
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Equipment
Objectives
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Equipment
Principle
Equipment must be
located
designed
constructed
adapted
maintained
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Equipment
Principle
And to avoid:
cross-contamination
dust and dirt build-up
any adverse effect on the quality of products
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Equipment
Pipes and pipings
Fixed pipework:
clearly labelled
indicate contents
direction of flow
Service pipings
adequately marked
non-interchangeable connections or adaptors
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Equipment
Balances and Measuring Equipment
Appropriate range
Precision
Available to:
production
quality control
Calibrated
scheduled basis
checks
records maintained
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Equipment
Production equipment
Design
easily and thoroughly cleaned
scheduled basis
Location
Maintenance
Defective equipment
removed
labelled
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Equipment
Control laboratory equipment
Defective equipment
removed
labelled
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Equipment
Washing and Cleaning
On scheduled basis
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