cgmp

1. CGMP
CGMP refers to Current Good
Manufacturing Practice (CGMP) regulations
enforced by US FDA.
Current Good Manufacturing Practices are the
methods to be used in, the facilities or controls
to be used for, the manufacturing, processing,
packaging or holding of a drug to assure that
such drug meets the requirements of the act,
and has the identity and strength and meets the
quality and purity characteristics that is
represented

2. Objectives
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 Ensure that products are consistently manufactured and
controlled to the specified quality.
 Concerned with all aspects of production and quality control.
 In the manufacture of cosmetic products, overall control and
monitoring
 Ensure that the consumer receives products of specified
quality.
The quality of a product depends on the starting
materials, production and quality control processes,
building, equipment and personnel involved.
 CGMP regulations assures the identity, strength, quality and
purity of drug products

3. Plant Layout
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Plant layout is a coordinated effort to
achieve the final objective to integrate
machines, materials, and personnel for
economic production.
Involves location of different
departments and arrangement of
machinery in each department.

4. TYPES OF PLANT LAYOUT
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Process layout or functional layout
Product or straight line layout
 Process layout or functional layout
Arrangement of machines of a particular class
doing a particular process as separate department
Advantage
More effective supervision
Division of labour can be provided
Disadvantage
May not be possible as a number of unit operations
have to be performed

5. Product or straight line layout
• The arrangement of machines doing
various operations in a line as one
department
Advantages
Processing of work is quick and smooth
Cost of handling is reduced using conveyers
Manufacturing time can be reduced
Floor space can be properly utilized
GOKULAKRISHNAN cGMP 5

6. FACTORS INFLUENCING PLANT LAYOUT
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Basic managerial policies and decisions
Nature of plant location
Type of industry and process
 Intermittent industries
 Continuous industries
Types of methods of production
 Job production
 Batch or lot production
 Continuous or mass production

7. STORES- LAYOUT
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Should be planned in the objectives of:
– Achieving minimum wastage of space
– Achieving maximum ease of operations
The layouts should:
 Make optimum utilization of floor space and height
 Should be 1.5- 3m wide to facilitate traffic
 Permit effective and orderly segregation of various
categories of materials and allow raotation of stock (1st
in 1st out)
 Should be ventilated
 Have provisions for storage as per specific conditions
 Adequately protected from waste, damge and
deterioration.

8. Lighting.
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 Adequate lighting shall be provided in all areas.
Ventilation, air filtration, air heating and cooling.
 Adequate ventilation shall be provided.
 Equipment for adequate control over air pressure, micro-
organisms, dust, humidity, and temperature shall be provided
appropriate for the manufacture, processing, packing, or
holding of a drug product.
 Air filtration systems, including prefilters and particulate
matter air filters, shall be used appropriate on air supplies to
production areas.

9. Plumbing
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 Potable Water shall be supplied under continuous positive
pressure in a plumbing system free of defects that could
contribute contamination to any drug product. Potable water
shall meet the standards as prescribed.
Sewage and refuse
 Sewage, trash, and other refuse from the building and premises
shall be disposed of in a safe and sanitary manner.
Washing and toilet facilities
 Adequate washing facilities shall be provided, including hot
and cold water, soap or detergent, air driers or single-service
towels, and clean toilet facilities easily accessible to working
areas.