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Module 9 Slide 1 of 25 WHO - EDM
PremisesPart One
Basic Principles of GMP
Part One, 11
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Module 9 Slide 2 of 25 WHO - EDM
PremisesObjectives
1. To review general requirements 2. To list key requirements for site choice3. To consider specific requirements for main areas 4. To list major facilities required in a multifunction
site
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Module 9 Slide 3 of 25 WHO - EDM
Part One, 11.1
PremisesPrinciple
Premises must be located, designed, constructed, adapted and maintained for the operations:
Minimize risks of errors and cross-contamination
Permit effective cleaning Permit effective maintenance Minimize build-up of dirt and dust Eliminate any adverse effects on quality
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Module 9 Slide 4 of 25 WHO - EDM
Part One, 11.1
Premises
Principle Premises must be
located to minimize risks of cross-contamination; e.g. not located next to a malting factory with high airborne levels of yeast
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Module 9 Slide 5 of 25 WHO - EDM
Part One, 11.2
PremisesLocation
Geography, climate, noise and economic factors Neighbours
What do they do? What impact can they have on the business?
Pollution/effluent control
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Module 9 Slide 6 of 25 WHO - EDM
Part One, 11.3 – 11.6
PremisesPremises should be built to:
Facilitate sanitation. Be maintained and cleaned easily Services availability Protection against entry of insects or other animals
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Module 9 Slide 7 of 25 WHO - EDM
Part One 11.7 – 11.10
PremisesAncillary Areas
Rest and refreshment rooms Changing, washing and toilet areas Maintenance workshops Animal houses
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Module 9 Slide 8 of 25 WHO - EDM
PremisesDesign Principles
Process flow Material flow People flow
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Module 9 Slide 9 of 25 WHO - EDM
Q C
Offices Gowning
Canteen Incoming
goods Corridor
Corridor Shipping
Corridor
Packaging
Weighing Processing
Filling
Raw Materials
& Packaging Storage
Washing
Machine
Shop
Finished Products Storage
Corridor Utilities and Services Waste Treatment
PremisesExample of Materials and People Flow
Arrival of goods Entrance for visitors Entrance for Workers Shipment of goods Material Flow People Flow
Zone: Clean Zone: Packaging Zone: Controlled
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Module 9 Slide 10 of 25 WHO - EDM
PremisesPart two
Basic Principles of GMP
Part One, 11
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Module 9 Slide 11 of 25 WHO - EDM
Part One 11.11 – 11.13
PremisesWarehouse – I
Storage areas of sufficient capacity for: Clean, dry and maintained within acceptable
temperature limits Area under cover, protection from heat, dirt, and
rain
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Module 9 Slide 12 of 25 WHO - EDM
Part One 11.14 –11.18
PremisesWarehouse – II
Areas clearly marked and access limited for quarantine status good.
QC sampling area with GMP standards Segregated areas for rejected, recalled and
returned materials Separate areas for highly active, hazardous,
narcotic materials Printed materials storage
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Module 9 Slide 13 of 25 WHO - EDM
Part One 11.19
PremisesWeighing areas
Control systems Environmental controls, dust control Segregation Smooth, impervious, durable, easy to clean finishes Cleaning Documentation
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Module 9 Slide 14 of 25 WHO - EDM
Part One 11.20 – 11.23
PremisesManufacturing and Packaging – I
Dedicated and self-contained facilities for: Logical flows of materials and people Adequacy of working space and orderly and
logical positioning of equipment Interior surfaces smooth/crack-free/easy to clean
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Module 9 Slide 15 of 25 WHO - EDM
PremisesOther Areas
Personnel rest areas/cafeterias/changing rooms away from operating areas prevention of cross-contamination prevention of operators going outside in work clothes provision of access control prevention of visitors access to operating areas
Maintenance service areas separated from production areas whenever possible
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Module 9 Slide 17 of 25 WHO - EDM
PremisesFinish of Floors, Walls and Ceilings
Difficult but not impossible to get right Smooth, impervious, hard-wearing, easy to
clean Resistant to operations and materials in use Windows not opening to the outside Avoid sliding doors
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Module 9 Slide 20 of 25 WHO - EDM
Part Two 15.12 (a)–(h)
PremisesCross-contamination
1. Segregated areas2. Airlocks and pressure differentials3. Treatment of recirculated air4. Protective clothing5. Effective cleaning procedures6. Closed production systems7. Residue testing8. Status labelling
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Module 9 Slide 21 of 25 WHO - EDM
Part One 11.24 – 11.26
PremisesManufacturing and Packaging – I
Pipework and other fittings sited to avoid recesses Drain design:
equipped to prevent backflow open channels avoided
Effective air handling to suit product temperature humidity filtration monitoring
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Module 9 Slide 22 of 25 WHO - EDM
Part One 11.27 – 11.28
PremisesManufacturing and Packaging – II
Specifically designed and laid out to avoid mix-ups and cross-contamination Changing facilities to provide segregated access
Prevention of cross-contamination Suitable lighting levels
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Module 9 Slide 23 of 25 WHO - EDM
Part One 11.29 – 11.32
PremisesIn-Process and QC laboratories
Located separate from but near manufacturing prevention of cross-contamination separate biological , microbiological,
radioisotopic areas Designed for the operations being carried out
suitable storage space