This document provides an overview of general requirements for pharmaceutical manufacturing premises according to Good Manufacturing Practice (GMP) standards. It discusses location, design, construction, and maintenance of facilities. Specific areas covered include ancillary areas, storage areas, weighing rooms, production areas, and quality control laboratories. Key requirements addressed are preventing cross-contamination, permitting effective cleaning and maintenance, and controlling temperature, humidity and air quality. The document aims to help ensure premises are suitable for intended operations and manufacturing of quality products.

1. Module 9 | Slide 1 of 46 2012
Premises
Part One
Basic Principles of GMP
12

2. Module 9 | Slide 2 of 46 2012
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 9 | Slide 3 of 46 2012
12.1
Premises
Principle
Important aspects to be kept in mind to ensure the suitability of
the operations to be carried out for different dosage forms and
product range:
 Location
 Design
 Construction
 Adaptation
 Maintenance

4. Module 9 | Slide 4 of 46 2012
12.1, 12.4
Premises
Location
 Geography, climate, noise and economic factors
 Neighbouring factories and sites
 What do they do?
 What impact can they have on the
business?
 Pollution/effluent control
 Minimum risk for contamination of products and materials

5. Module 9 | Slide 5 of 46 2012
12.4
Premises
Principle
 Premises must be
located, designed, and
with a layout to
minimize risks of
cross-contamination,
e.g. not located next
to a malting factory with
high airborne levels of
yeast

6. Module 9 | Slide 6 of 46 2012
12.2
Premises
General
The layout and design should aim to:
 Avoid any adverse effect on the quality of products
 Avoid cross-contamination, build-up of dirt and dust
 Minimize risks of errors
 Permit effective cleaning
 Permit effective maintenance

7. Module 9 | Slide 7 of 46 2012
Premises
Design Principles
Ensure logical flow. Keep in mind:
 Material flow
 People flow
 Process flow
(Look at the layouts and see how people, materials
and products flow)
12.10

8. Module 9 | Slide 8 of 46 2012
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
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

9. Module 9 | Slide 9 of 46 2012
12.5, 12.7, 12.9
Premises
Design
 Suitable design and construction to facilitate good
sanitation
 Cleaning and disinfecting according to detailed written
procedures – records maintained
 Maximum protection against entry of insects, birds and
animals
 Procedure for rodent and pest control implemented

10. Module 9 | Slide 10 of 46 2012
12.8, 12.32
Premises
Construction and utilities
 Suitable construction materials
 Electrical supply
 Suitable lighting (especially for visual on-line checks)
 Temperature and relative humidity
– Controlled, monitored and recorded
 Appropriate and effective ventilation
These may affect products during manufacture or
storage as well as functioning of equipment

11. Module 9 | Slide 11 of 46 2012
Basic Principles of GMP
 The temperature and
relative humidity should
be controlled, monitored
in accordance with an
SOP, and the results
recorded.
 The limits should be
appropriate according to
the storage requirements
for materials and
products

12. Module 9 | Slide 12 of 46 2012
12.3
Premises
Construction
 Dust generating operations
 e.g. sampling, weighing, mixing, packing of
powders, etc.
 Measures should be taken to prevent cross-
contamination
 Measures to facilitate cleaning
– E.g. Materials of construction; ledges and edges; smooth
surfaces

13. Module 9 | Slide 13 of 46 2012
Basic Principles of GMP
Design of areas for
weighing of materials
 Proper air supply
 Dust control measures
(including extraction of dust
and air)
 Easily cleanable surfaces
 No areas for dust
accumulation
 Protection of material,
product and operator

14. Module 9 | Slide 14 of 46 2012
12.6
Premises
Maintenance
 Procedure for maintenance of the premises
 Records maintained
 Damage repaired
 Repairs and maintenance should not present any
hazard to the quality of the products
 What should be done if there is any damage while a
product is being processed?

15. Module 9 | Slide 15 of 46 2012
Basic Principles of GMP

16. Module 9 | Slide 16 of 46 2012
12.11 – 12.36
Premises
Specific areas
In Part 2 – we will review some recommendations for specific
areas such as:
 Ancillary areas
 Storage areas
 Weighing areas
 Production areas
 Quality control areas

17. Module 9 | Slide 17 of 46 2012
Premises
Part two
Basic Principles of GMP
12

18. Module 9 | Slide 18 of 46 2012
12.11 – 12.14
Premises
Ancillary Areas
 Rest and refreshment rooms: Separate from production and
quality control areas
 Changing, washing and toilet areas accessible and appropriate
numbers
 Animal houses well isolated – separate air handling and
entrance
 Maintenance workshops: Separated from production - if not
possible – tools in reserved areas

19. Module 9 | Slide 19 of 46 2012
Basic Principles of GMP
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20. Module 9 | Slide 20 of 46 2012
Basic Principles of GMP

21. Module 9 | Slide 21 of 46 2012
Basic Principles of GMP
Separate receiving
and dispatch bay
Protect materials and
products from
weather
Area to clean
incoming materials
provided
12.17

22. Module 9 | Slide 22 of 46 2012
Basic Principles of GMP
Cleaning of incoming
containers
 Cleaning with a cloth, or
duster
 Cleaning by using a
vacuum cleaner
 Use of air curtains and
air tunnels

23. Module 9 | Slide 23 of 46 2012
12.15, 12.16
Premises
Storage areas - 1
 Sufficient capacity, orderly storage of categories of
materials and products
 Storage conditions
 Separate and segregated areas
– starting materials, packaging materials, intermediates, bulk,
finished products, quarantined, released, rejected, returned
and recalled products and materials

24. Module 9 | Slide 24 of 46 2012
Basic Principles of GMP

25. Module 9 | Slide 25 of 46 2012
Basic Principles of GMP

26. Module 9 | Slide 26 of 46 2012
12.16
Premises
Storage areas - 2
 Good storage conditions
– Clean
– Dry
– Temperatrure
– Lights
 Within defined limits
Provided, controlled,
Monitored and recorded

27. Module 9 | Slide 27 of 46 2012
12.18 – 12.20, 12.22
Premises
Storage areas - 3
 Separated areas recommended - clearly marked and access
restricted e.g.:
– Quarantine area
 Segregate areas:
 Rejected, recalled and returned materials and products
 Separate sampling area recommended to prevent risk for
contamination or cross-contamination
 Safe and secure areas for highly active, radioactive materials,
narcotics and other materials (risk of abuse, fire, explosion)

28. Module 9 | Slide 28 of 46 2012
Basic Principles of GMP

29. Module 9 | Slide 29 of 46 2012
12.21
Premises
Storage areas – 4
Printed packaging materials
 Correct materials are critical to ensure compliance with correct
labelling of products
 Ensure compliance with specifications, prevent mix-ups
 Special attention to:
– Sampling
– safe and secure storage

30. Module 9 | Slide 30 of 46 2012
12.23
Premises
Weighing areas
 Weighing operations – in separated areas
 Appropriate design (see also training material on HVAC)
 Provision for dust control
 Smooth, impervious, durable, easy-to-clean finishes
 Cleaning procedures and records
 Documentation, e.g. SOPs, logs and records

31. Module 9 | Slide 31 of 46 2012
Basic Principles of GMP

32. Module 9 | Slide 32 of 46 2012
12.24
Premises
Production areas - 1
Minimize risk of cross-contamination:
 Dedicated and self-contained facilities for some products such
as highly sensitizing materials (e.g. penicillins) or biological
preparations (e.g. live microorganisms)
 Separate facilities for other products such as some antibiotics,
hormones, cytotoxic substances
 Non-pharmaceuticals normally not in the same facility, e.g.
pesticides, herbicides

33. Module 9 | Slide 33 of 46 2012
12.32, 12.26, 12.31
Premises
Production areas -2
 Layout in accordance with sequence of production (flow)
 Layout to avoid mix-ups and cross-contamination
 Orderly and logical positioning of equipment
 minimizes risk of contamination, mix-ups and missing
production steps
 Appropriate cleanliness level, and lights
 Adequate work and in-process storage space

34. Module 9 | Slide 34 of 46 2012
12.32, 12.26, 12.31
Premises
Production areas -2
 Specially designed areas for packaging
 Layout
 Space
 No mix-ups

35. Module 9 | Slide 35 of 46 2012
12.27
Premises
Production areas - 3
 Starting and packaging materials, intermediates and bulk
exposed to environment:
 Interior surfaces (walls, floors, ceilings) – smooth, free from
cracks and open joints
 No shedding of particles
 Easy and effective cleaning permitted
 Disinfection if needed

36. Module 9 | Slide 36 of 46 2012
12.28, 12.29
Premises
Production areas - 4
 Design of pipework, light fittings, and ventilation points
– no recesses that are difficult to clean
 Access for maintenance from outside production areas
 Drains
– adequate size
– equipped to prevent back-flow
 Open channels avoided

37. Module 9 | Slide 37 of 46 2012
Basic Principles of GMP

38. Module 9 | Slide 38 of 46 2012
12.30
Premises
Production areas - 5
 Effective ventilation with air control facilities
 Including filtration of air to a sufficient level to prevent
contamination and cross-contamination – also external
environment
 Control of temperature and relative humidity where
necessary
 Regular monitoring of conditions during production and non-
production periods

39. Module 9 | Slide 42 of 46 2012
12.33, 12.34
Premises
Quality Control areas - 1
 QC laboratories should be separate from production areas
 Separate areas for biological, microbiological and radioisotope
methods
 Suitable design with sufficient space to avoid mix-ups and
cross-contamination
 Suitable space for storage samples, reference standards,
solvents, reagents and records

40. Module 9 | Slide 43 of 46 2012
Basic Principles of GMP

41. Module 9 | Slide 44 of 46 2012
12.35, 12.36
Premises
Quality Control areas - 2
 Suitable construction materials
 Prevention of fumes
 Ventilation
 Separate air supply (production and QC)
 Separate rooms for some instruments to protect them from
interference (e.g. electrical, vibration, moisture, etc.)
See supplementary training on QC laboratories

42. Module 9 | Slide 45 of 46 2012
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

43. Module 9 | Slide 46 of 46 2012
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?