Pharmaceutical Quality Assurance (QA) is a comprehensive system designed to ensure that pharmaceutical products meet the highest standards of safety, efficacy, and quality throughout their lifecycle. Central to QA is strict adherence to regulatory requirements set by agencies such as the FDA and EMA, which guide manufacturers in implementing Good Manufacturing Practices (GMP). A robust QA framework incorporates risk management strategies to identify and mitigate potential hazards, alongside thorough documentation and traceability to ensure accountability and transparency. Continuous improvement is emphasized through methods like Corrective and Preventive Actions (CAPA), while employee training ensures that staff are competent in quality standards. Additionally, systematic validation of processes and regular quality control testing are vital for maintaining product integrity. Supplier quality management is equally important, ensuring that all raw materials meet rigorous quality criteria. Ultimately, a strong focus on customer needs drives the commitment to excellence, fostering trust and reliability in pharmaceutical products.

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NANDHA COLLEGE OF
PHARMACY
ERODE – 638052, TAMILNADU
NAME: DAKSHINESH P
COURSE :B.PHARM
SEMESTER :VI-SEMESTER

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PHARMACEUTICAL QUALITY
ASSURANCE
PREMISES

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OUTLINE
INTRODUCTION
DESIGN
CONSTRUCTION
PLANT LAYOUT
MAINTENANCE

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INTRODUCTION
PREMISES:
The building and the land considered together with measures to
protect the manufacture, presents minimal causing contamination of
materials or products.
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 site.

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PRINCIPLE:
Premises must be located, designed, constructed, and maintained for the
operations like
• 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.
• 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

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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.

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Factors which must be mainly taken into consideration while selecting
the site for pharma industry are
Transportation facility
Availability of water, electricity
Maintenance facility for repair
Fuel availability, sewage and waste stream removal from plant
Proximity for civil facilities for factory personals
Adequate space for future expansion
Adequate security arrangements

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Factors for location :
*Fundamental (primary) factors
*Derived (secondary) factors
Fundamental (primary) Factors:
• Raw materials
• Market
• Energy availability
• Transportation facility Labour
supply
Derived (secondary) factors :
• Climate and soil
• Government concession
• Water supply
• Waste disposal
• Site Characteristics
• Flood and Fire Protection
• Community Factors

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CONSTRUCTION
Construction of the building should be such that it ensures protection of the
product from contamination.
The premises used for manufacturing, processing, warehousing, packaging
labeling and testing purposes shall be :-
1. Compatible with other drug manufacturing operations.
2. Proper Space for Working should be there.
3. Proper logically placement of equipment and material.
4. Avoid the risk of mix-up between different categories of drugs or with
raw materials, intermediates and in-process material.

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5. Control the cross contamination by other drugs or substances.
6. Deign should such that it prevent the entry insect and rodents.
7. Interior surface (walls, floors and ceilings) shall be smooth and free
from cracks, and permit easy cleaning, painting and disinfection.
8. Provide with adequate lighting and ventilation, if necessary air
conditioning to maintain a satisfactory temperature.
9. The interior surfaces shall not shed particles.
10. A periodical record of cleaning and painting of the premises shall be
maintained.
11. It should be proper underground drainage system in the processing
area as far as possible.
12. Sanitary fitting and electrical should be concealed.

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CONSTRUCTION MATERIALS:
The materials used for the construction must be of good quality
Wall
Floors
Ceilings
Doors and windows
FACILITIES:
Lighting
Air conditioning
Planning
Sewage and refuse
Washing and toilet facilities

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PLANT LAYOUT
Plant layout refers to the arrangement of physical facilities such as
machines, equipment, tools, furniture etc. in such a manner so as to have
quickest flow of material at the lowest cost and with the least amount of
handling in processing the product from the receipt of raw material to
the delivery of the final product.
TYPES OF LAYOUT:
There are mainly four types of plant layout:
(a) Product or straight line layout
(b) Process or functional layout
(c) Fixed position or location layout
(d) Combined or group layout

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Product or straight line layout :
The arrangement of machines doing various operation in a line as
one department.
E.g. In manufacture of tablet; Dispensing, powder blending,
granulation, drying , compression and coating. All of the above look as
different operation but logically arranged in a series.

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Process layout or Functional layout:
It the arrangement of machines of a particular class doing a
particular type of work or process as a separate department.
E.g. All cutting machines may be placed in one department. i.e. cutting
department.
Combined layout:
A combination of process & product layout is known as
combined layout.
Manufacturing concerns where several products are produced in
repeated numbers with no likelihood of continuous production,
combined layout is followed.

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Fixed position or location layout:
• Fixed position layout involves the
movement of manpower and machines to
the product which remains stationary.
• The movement of men and machines is
advisable as the cost of moving them would
be lesser.
• This type of layout is preferred where the
size of the job is bulky and heavy.
• Example of such type of layout is
locomotives, ships, boilers, generators,
wagon building, aircraft manufacturing, etc.

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MAINTENANCE
• Any building used in the manufacture,
processing, packing, or holding of a drug
product shall be maintained in a good state
of repair.
• Deterioration of buildings not only presents
a poor image of the facility, it can also
impact on product quality.
• Cracks and holes in walls, floors, or
ceilings can provide access for insects,
rodents, birds, dirt, or microorganisms.

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• They can also hinder cleaning and sanitation, thereby increasing the
potential for cross contamination or microbial multiplication
• Floor cracks can also become a safety hazard for people or even
dislodge materials from trucks.
• The ingress of water from roof leaks can cause significant damage to
materials and equipment, give rise to electrical failures and fires and
result in damage to the basic structure of the building.
• Additionally , holes in the roof or near the tops of buildings provide
ready access to birds, which may then be encouraged to nest within the
building.

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THANK YOU