Premises

1
Basic Principles of GMP
Premises Part One
Part One, 11
2
Premises

• Objectives
• 1. To review general requirements
• 2. To list key requirements for site choice
• 3. To consider specific requirements for main
  areas
• 4. To list major facilities required in a
  multifunction site

3
Premises

• Principle
• 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

Part One, 11.1
4
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

Part One, 11.1
5
Premises

• Location
• Geography, climate, noise and economic factors
• Neighbours
• What do they do?
• What impact can they have on the business?
• Pollution/effluent control
  

Part One, 11.2
6
Premises

• Premises should be built to
• Facilitate sanitation.
• Be maintained and cleaned easily
• Services availability
• Protection against entry of insects or other
  animals

Part One, 11.3 11.6
7
Premises

• Ancillary Areas
• Rest and refreshment rooms
• Changing, washing and toilet areas
• Maintenance workshops
• Animal houses

Part One 11.7 11.10
8
Premises

• Design Principles
• Process flow
• Material flow
• People flow

9
Premises

• Example 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
• 
  
  
• 
  

10
Basic Principles of GMP
Premises Part two
Part One, 11
11
Premises

• Warehouse I
• Storage areas of sufficient capacity for
• Clean, dry and maintained within acceptable
  temperature limits
• Area under cover, protection from heat, dirt, and
  rain

Part One 11.11 11.13
12
Premises

• Warehouse 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

Part One 11.14 11.18
13
Premises

• Weighing areas
• Control systems
• Environmental controls, dust control
• Segregation
• Smooth, impervious, durable, easy to clean
  finishes
• Cleaning
• Documentation

Part One 11.19
14
Premises

• Manufacturing 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

Part One 11.20 11.23
15
Premises

• Other 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

16
Premises

• Windows should not open to the outside

17
Premises

• Finish 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

18
Premises
Not this

• Finish of Floors, Walls and Ceilings
• Difficult but not impossible to get right,
  smooth, impervious, hard-wearing, easy to clean
  but not bricks, tiles, wood or sliding doors!

19
Premises

• Finish of Floors, Walls and Ceilings
• Much better

20
Premises

• Cross-contamination
• 1. Segregated areas
• 2. Airlocks and pressure differentials
• 3. Treatment of recirculated air
• 4. Protective clothing
• 5. Effective cleaning procedures
• 6. Closed production systems
• 7. Residue testing
• 8. Status labelling

Part Two 15.12 (a)(h)
21
Premises

• Manufacturing 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

Part One 11.24 11.26
22
Premises

• Manufacturing 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

Part One 11.27 11.28
23
Premises

• In-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

Part One 11.29 11.32
24
Premises

• Group Session - Option 1
• A company wishes to manufacture simple
  non-sterile medicines. It has engaged a
  consultant to draw up some building plans.
• Comment on the building plans faxed through to
  your group.
• Comment on the people flow, the process flow and
  the material flow.

25
Premises

• Group Session - Option 2
• Consider a multifunction factory producing
  sterile and non-sterile products
• What GMP facilities would you expect to find in
  this factory?
• What would you look for in the quality of those
  facilities and what weaknesses might you find?
• How can companies overcome those weaknesses?