When designing a pharmaceutical manufacturing facility, the ways in which materials are moved from one stage of production to another should be considered from the very beginning. so the drug industry location and design considered crucial and should be according to GMP standards.

1. DRUG INDUSTRY
LOCATION &
DESIGN
MANSI NARENDRASINH
CHAUHAN
M.Pharm

2. QUALITY CONTROL AND QUALITY ASSURANCE
TOPIC: DRUG INDUSTRY LOCATION & DESIGN
PR ESEN TED BY
MA N SI N A R EN D R A SIN H C H A U H A N
M.PHARM
PH AR MAC EU TIC AL QU ALITY ASSU R AN C E
3/28/2022
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Guided by
Ms. Priya
Shukla
Smt. BNB Swaminarayan Pharmacy
College Salvav-Vapi

3. CONTENTS
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 Quality control & quality assurance
 Introduction
 Drug industry location
 Factors affecting location
 Drug industry design
 Design & construction
 Site development plan
 Separate area allotment
 Plant design guidelines
 Premises design

4.  Quality can be defined as “fitness for use”, “customer satisfaction”, “doing
things right the first time”, or “zero defects”.
 Quality is defined as “an inherent characteristic, property or attribute.
 Quality control includes various techniques and activities of an organization that
are involved in monitoring & improving the business so that the products processes
or services meet the standard specifications. Also involves reviewing the processes
& specifications and to make recommendation for their improvement.
 Quality assurance includes all the planned & systemic activities required for
assuring that a product or service will meet the specifications.
 The difference between both is that, the former makes quality product and later
assures the same.
Quality Control & Quality Assurance
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5. INTRODUCTION
 WHO Defines Good manufacturing practice is that part of quality assurance
which ensures that products are consistently produced and controlled to the
quality standards appropriate to their intended use and as required by the
marketing authorization, clinical trial authorization, or product specification.
 GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical
production that ensures quality, safety & efficacy of products.
 CGMP refers to the Current Good Manufacturing Practice regulations enforced
by the FDA. CGMPs provide systems that assures proper design, monitoring, and
control of manufacturing processes and facilities. Adherence to the CGMP
regulations assures the identity, strength, quality, and purity of drug products.
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6. LOCATION
 The location, environment, plant layout, design and
construction of premises directly or indirectly affect the
quality of pharmaceuticals, thus play role a significant role
in pharmaceuticals. Therefore, a thorough analysis of the
selectionof location ofpremises,environment,plant layout,
design&construction ofpremises shouldbedone.
 The location for the construction of a pharmaceutical plant
should be appropriately selected as it determines the
balancing of investment & profit. While selecting the
location of premises, one should consider both the external
andtheinternal environment.
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7. FACTORS AFFECTING LOCATION
1) Availability of water, power, fuel, sewage, and waste-stream removal
2) Applicable laws
3) Proper space for future expansion
4) Accessibility for employees, materials, and visitors
5) Environmental issues, like water and air quality, etc.
6) Nearness of undesirable activities that can pollute or act as a source of microbial
contamination
7) Availability of suitable labor force
8) Availability of proper security arrangements
9) Accessibility to inter-related operations of the company
10) Political situations like government stability, trade policies and taxation, financial
incentives, etc.
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8. DRUG
INDUSTRY
DESIGN

9. DESIGN AND CONSTRUCTION
 The premises to be used for the manufacturing, processing, packing or
holding of drug products should be of suitable size, design, construction
and location.
 The premises should also abide by the conditions laid down in the
Factories Act, 1948.
 Adequate space should be present within the premises so that the
equipment can be arranged orderly and mixing and contamination of
the materials can be avoided.
 The flow of materials and personnel through the building or facilities
should be designed such a way that mix-ups or contamination can be
avoided.
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10. SITE DEVELOPMENT PLAN
1) Site resources and infrastructure, like green spaces, parking, & road,
2) Storm water and waste management,
3) Compliance with appropriate laws and regulations,
4) Site security and access, like installation of fences, guard posts, cameras, etc.,
5) Layout, usage and possible expansion of buildings,
6) Utilities, like design, layout, and electricity backups,
7) Equipment, like design, layout, spares, and capacity,
8) Pedestrian and vehicular traffic flow,
9) Safety for personnel and equipment,
10) External architecture to consider the local environmental conditions,
11) Ease of maintenance and cleaning,
12) Selection and use of experienced contractors,
13) Identification of project management responsibility,
14) Validation plans and an effective change control procedure, & construction material
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11. A SEPARATE AREA ALLOTMENT
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1) Receipt, identification, sampling, and quarantine
of incoming materials, pending release or
rejection,
2) Quarantine before release or rejection of
intermediates and APIs,
3) Sampling of intermediates and APIs,
4) Holding rejected materials before further
disposition (e.g., return, reprocessing, or
destruction),
5) Storing released materials,
6) For production related operations,
7) For packaging and labelling operations,
8) For operations performed in laboratory.
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12. PLANT DESIGN GUIDELINES
 The walls should be positioned such that they enable orderly movement of
materials and personnel.
 The inter-relationship of different operations should minimize cross-
contamination and for component mix-up during storage and interdepartmental
shipping.
 High-quality concrete blocks or gypsum board with plaster finish should be used
for making walls m corridors, manufacturing and packaging areas.
 The finish of these walls should he smooth and with enamel or epoxy paint. Pre-
fabricated partitions should be used in packaging areas where flexibility of
layout is required.
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walls

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Gypsum wall board
Welded sheet PVC

14. Floor coverings should be such that they are durable, easily cleanable, and resistance
to the chemicals with which it would come into contact. Flooring should be
washable, smooth, without cracks and crevices, and should not allow dust
accumulation. Given below are some commonly used coverings:
i) Terrazzo: It provides a hard-wearing finish. It is available in tiles as well as
poured-in-place finishes. The latter is preferred for manufacturing. Tiles should be
used carefully to ensure that they are effectively sealed, or else dirt and
microorganisms can accumulate in the gaps between two tiles.
ii) Ceramic and Vinyl Tiles: They are not recommended for production areas.
iii) Welded Vinyl Sheeting: It provides a smooth and easily cleanable surface. It is
preferred in production areas, especially for injectables because lack of joints
improves the ease of cleaning and sanitation.
iv) Epoxy Flooring: It provides durability and cleanability to the surface.
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Floors

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Terrazzo Ceramic & vinyl tiles
Welded vinyl sheeting Epoxy flooring

16.  Ceilings Office areas, laboratories, toilets, and cafeterias consisting of
lay in acoustical panels of non-brittle, non-friable, non-asbestos, and
non combustible material should have suspended ceilings.
 In the manufacturing areas, the ceilings should be of seamless plaster or
gypsum board with a smooth finish.
 All ceiling fixtures, like light fittings, air outlets and returns and
sprinkler heads should be so designed that they permit cleaning reduce
dust accumulation.
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Ceilings

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18. • Adequate provisions should be made for drainage, water, steam electricity, and
other services for easy maintenance of the buildings.
• The design and facilities of buildings should be such that they have sufficient
space for orderly arrangement of equipment and materials so that any mix, ups
and contamination do not occur.
• Adequate cleaning, washing and toilet facilities should also be provided for the
personnel.
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Services

19. • Adequate amount of light (lux or foot-candles) should reach the working surface
of each area involved in the production of pharmaceuticals.
• There are public standards for some types of work. Normally, range of 30 to 50
foot-candles is suitable to provide work comfort and ability to perform
efficiently and effectively; however, some areas demand 100 foot candles along
with special lighting for some operations, such as inspection of filled vials.
• After defining the light levels, they should be measured periodically to record the
results.
• The specifications should demand either replacement of light sources when they
have reached some level above the established minimum or routine replacements
of light sources on scheduled time to ensure that light levels do not reach below
the established minimum.
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Lighting

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21. PREMISES
DESIGN
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22. ANCILLARY AREA
changing/gowni
ng room
Refreshment
room
Workshops Animal house
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23. STORAGE AREAS
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24. WEIGHING AREAS
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25. PRODUCTION AREAS
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1 Mechanical
room
2 storage & logistic
areas
3 processing
areas
4 production
areas
5 restrooms &
changing areas
6 Laboratory &
Research Areas
7 Cafeteria & Break
Spaces
8 Lobby &
Corridors
Offices &
Conference
Rooms
9
Workspac
es
Plant layout

27. References
 Dr. R. sundhararajan, DR. M. V. kumudhavalli, Dr. minal T harde.
2019-20. “quality assurance”. Thakur publication Pvt. Ltd.
 “Pharmaceutical facility design” NJIT(New jersey institute of
technology.
 Quality assurance of pharmaceuticals: a compendium of guidelines,
volume 2, by world health organization.
 https://www.who.int/medicines/areas/quality_safety/quality_assurance/
QualityAssurancePharmVol2.pdf
 www.who.org.htm
 www.fda.gov.in.htm
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