Transcript Premises - KRISHNAVENI PHARMA CONSULTANCY

Basic Principles of GMP
Premises
Part One
Part One, 11
Module 9
Slide 1 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
Module 9
Slide 2 of 25
WHO - EDM
Premises
Principle
Premises must be located, designed, constructed, adapted
and maintained for the operations:
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Minimize risks of errors and cross-contamination

Permit effective cleaning
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Permit effective maintenance
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Minimize build-up of dirt and dust
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Eliminate any adverse effects on quality
Part One, 11.1
Module 9
Slide 3 of 25
WHO - EDM
Premises
Principle

Premises must be
located to minimize
risks of crosscontamination; e.g. not
located next to a
malting factory with
high airborne levels of
yeast
Part One, 11.1
Module 9
Slide 4 of 25
WHO - EDM
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
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Slide 5 of 25
WHO - EDM
Premises
Premises should be built to:

Facilitate sanitation.
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Be maintained and cleaned easily

Services availability

Protection against entry of insects or other animals
Part One, 11.3 – 11.6
Module 9
Slide 6 of 25
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Premises
Ancillary Areas

Rest and refreshment rooms
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Changing, washing and toilet areas
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Maintenance workshops

Animal houses
Part One 11.7 – 11.10
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Slide 7 of 25
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Premises
Design Principles
Module 9

Process flow

Material flow

People flow
Slide 8 of 25
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Premises
Example of Materials and People Flow
Arrival of goods
QC
Entrance for visitors Entrance for Workers Shipment of goods
Offices
Canteen
Gowning
Incoming
goods
Corridor
Shipping
Corridor
Corridor
Raw
Materials
&
Packaging
Storage
Weighing
People Flow
Processing
Filling
Packaging
Finished
Products
Storage
Zone: Clean
Zone: Packaging
Zone: Controlled
Washing
Machine
Shop
Utilities and Services
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Material Flow
Slide 9 of 25
Corridor
Waste Treatment
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Basic Principles of GMP
Premises
Part two
Part One, 11
Module 9
Slide 10 of 25
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Premises
Warehouse – I

Storage areas of sufficient capacity for:
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Clean, dry and maintained within acceptable temperature
limits
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Area under cover, protection from heat, dirt, and rain
Part One 11.11 – 11.13
Module 9
Slide 11 of 25
WHO - EDM
Premises
Warehouse – II

Areas clearly marked and access limited for quarantine
status good.

QC sampling area with GMP standards
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Segregated areas for rejected, recalled and returned
materials

Separate areas for highly active, hazardous, narcotic
materials
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Printed materials storage
Part One 11.14 –11.18
Module 9
Slide 12 of 25
WHO - EDM
Premises
Weighing areas

Control systems

Environmental controls, dust control
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Segregation
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Smooth, impervious, durable, easy to clean finishes

Cleaning
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Documentation
Part One 11.19
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Slide 13 of 25
WHO - EDM
Premises
Manufacturing and Packaging – I
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Dedicated and self-contained facilities for:
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Logical flows of materials and people
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Adequacy of working space and orderly and logical
positioning of equipment
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Interior surfaces smooth/crack-free/easy to clean
Part One 11.20 – 11.23
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Slide 14 of 25
WHO - EDM
Premises
Other Areas
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Personnel rest areas/cafeterias/changing rooms
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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 15 of 25
WHO - EDM
Premises
Finish of Floors, Walls and Ceilings

Difficult but not impossible to get right
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Smooth, impervious, hard-wearing, easy to clean
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Resistant to operations and materials in use
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Windows not opening to the outside
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Avoid sliding doors
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Slide 17 of 25
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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
Module 9
Slide 20 of 25
Part Two 15.12 (a)–(h)
WHO - EDM
Premises
Manufacturing and Packaging – I

Pipework and other fittings sited to avoid recesses
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Drain design:
 equipped to prevent backflow
 open channels avoided

Effective air handling to suit product
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
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temperature
humidity
filtration
monitoring
Slide 21 of 25
Part One 11.24 – 11.26
WHO - EDM
Premises
Manufacturing and Packaging – II
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Specifically designed and laid out to avoid mix-ups and
cross-contamination
 Changing facilities to provide segregated access
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Prevention of cross-contamination

Suitable lighting levels
Part One 11.27 – 11.28
Module 9
Slide 22 of 25
WHO - EDM
Premises
In-Process and QC laboratories
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Located separate from but near manufacturing
 prevention of cross-contamination
 separate biological , microbiological, radioisotopic areas
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Designed for the operations being carried out
 suitable storage space
Part One 11.29 – 11.32
Module 9
Slide 23 of 25
WHO - EDM
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.
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Comment on the building plans “faxed” through to
your group.

Comment on the people flow, the process flow and
the material flow.
Module 9
Slide 24 of 25
WHO - EDM
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?
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Slide 25 of 25
WHO - EDM