module 9slide 1 of 25 who - edm premises part one basic principles of gmp part one, 11

Module 9 Slide 1 of 25 WHO - EDM

PremisesPart One

Basic Principles of GMP

Part One, 11

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

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

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

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

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

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

Module 9 Slide 8 of 25 WHO - EDM

PremisesDesign Principles

Process flow Material flow People flow

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

Module 9 Slide 10 of 25 WHO - EDM

PremisesPart two

Basic Principles of GMP

Part One, 11

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

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

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

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

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

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

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

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

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

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