1. Module 9Slide 1 of 25 WHO - EDM Premises Part One Basic Principles of GMP Part One, 11

2. Module 9Slide 2 of 25 WHO - EDM 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. Module 9Slide 3 of 25 WHO - EDM Part One, 11.1 Premises Principle Premises must be located, designed, constructed, adapted and maintained for the operations: l Minimize risks of errors and cross-contamination l Permit effective cleaning l Permit effective maintenance l Minimize build-up of dirt and dust l Eliminate any adverse effects on quality

4. Module 9Slide 4 of 25 WHO - EDM Part One, 11.1 Premises Principle l 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

5. Module 9Slide 5 of 25 WHO - EDM Part One, 11.2 Premises Location l Geography, climate, noise and economic factors l Neighbours ä What do they do? ä What impact can they have on the business? l Pollution/effluent control

6. Module 9Slide 6 of 25 WHO - EDM Part One, 11.3 – 11.6 Premises Premises should be built to: l Facilitate sanitation. l Be maintained and cleaned easily l Services availability l Protection against entry of insects or other animals

7. Module 9Slide 7 of 25 WHO - EDM Part One 11.7 – 11.10 Premises Ancillary Areas l Rest and refreshment rooms l Changing, washing and toilet areas l Maintenance workshops l Animal houses

8. Module 9Slide 8 of 25 WHO - EDM Premises Design Principles l Process flow l Material flow l People flow

9. Module 9Slide 9 of 25 WHO - EDM 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. Module 9Slide 10 of 25 WHO - EDM Premises Part two Basic Principles of GMP Part One, 11

11. Module 9Slide 11 of 25 WHO - EDM Part One 11.11 – 11.13 Premises Warehouse – I l Storage areas of sufficient capacity for: l Clean, dry and maintained within acceptable temperature limits l Area under cover, protection from heat, dirt, and rain

12. Module 9Slide 12 of 25 WHO - EDM Part One 11.14 –11.18 Premises Warehouse – II l Areas clearly marked and access limited for quarantine status good. l QC sampling area with GMP standards l Segregated areas for rejected, recalled and returned materials l Separate areas for highly active, hazardous, narcotic materials l Printed materials storage

13. Module 9Slide 13 of 25 WHO - EDM Part One 11.19 Premises Weighing areas l Control systems l Environmental controls, dust control l Segregation l Smooth, impervious, durable, easy to clean finishes l Cleaning l Documentation

14. Module 9Slide 14 of 25 WHO - EDM Part One 11.20 – 11.23 Premises Manufacturing and Packaging – I l Dedicated and self-contained facilities for: l Logical flows of materials and people l Adequacy of working space and orderly and logical positioning of equipment l Interior surfaces smooth/crack-free/easy to clean

15. Module 9Slide 15 of 25 WHO - EDM Premises Other Areas l Personnel rest areas/cafeterias/changing rooms ä away from operating areas ä prevention of cross-contamination ä prevention of operators going outside in work clothes ä provision of access control ä prevention of visitors access to operating areas l Maintenance service areas ä separated from production areas whenever possible

16. Module 9Slide 16 of 25 WHO - EDM Premises l Windows should not open to the outside

17. Module 9Slide 17 of 25 WHO - EDM Premises Finish of Floors, Walls and Ceilings l Difficult but not impossible to get right l Smooth, impervious, hard-wearing, easy to clean l Resistant to operations and materials in use l Windows not opening to the outside l Avoid sliding doors

18. Module 9Slide 18 of 25 WHO - EDM Premises Finish of Floors, Walls and Ceilings l Difficult but not impossible to get right, smooth, impervious, hard-wearing, easy to clean; but not bricks, tiles, wood or sliding doors! Not this

19. Module 9Slide 19 of 25 WHO - EDM Premises Finish of Floors, Walls and Ceilings Much better

20. Module 9Slide 20 of 25 WHO - EDM Part Two 15.12 (a)–(h) 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

21. Module 9Slide 21 of 25 WHO - EDM Part One 11.24 – 11.26 Premises Manufacturing and Packaging – I l Pipework and other fittings sited to avoid recesses l Drain design: ä equipped to prevent backflow ä open channels avoided l Effective air handling to suit product ä temperature ä humidity ä filtration ä monitoring

22. Module 9Slide 22 of 25 WHO - EDM Part One 11.27 – 11.28 Premises Manufacturing and Packaging – II l Specifically designed and laid out to avoid mix-ups and cross-contamination ä Changing facilities to provide segregated access l Prevention of cross-contamination l Suitable lighting levels

23. Module 9Slide 23 of 25 WHO - EDM Part One 11.29 – 11.32 Premises In-Process and QC laboratories l Located separate from but near manufacturing ä prevention of cross-contamination ä separate biological, microbiological, radioisotopic areas l Designed for the operations being carried out ä suitable storage space