good manufacturing practices

1. OBJECTIVE AND POLICIES OF
cGMP, LAYOUT OF BUILDINGS AND
SERVICES
Submitted By :
Shiva Kant Thakur
M. Pharm 1st year ( pharmaceutics )
Submitted To :
Dr . Himmat Singh Chawda
Modern Pharmaceutics M . Pharma Pharmaceutics

2. GMP
cGMP
Importance of cGMP
Objective of cGMP
Policy of cGMP
Layout of buildings , services and equipment
CONTENTS

3.  Good manufacturing practice.
 That part of quality assure which ensure that the products are consistently produced
and controlled .
 The quality standards appropriate to their intended use and as required by marketing
authorization .
GMP

4.  cGMP refers to Current Good Manufacturing Practices (CGMP) regulations enforced
by US FDA .
 CGMP 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 to possess.
cGMP

5. OBJECTIVES
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 is
required.
Ensure that the
consumer receives
products of
specified quality.

6. 1. PLANT LAYOUT
2. STORE LAYOUT
LAYOUT OF BUILDINGS

7. 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.
1.PLANT LAYOUT

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

9.  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.
CONTINUE…..

10. 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
FACTOR INFLUENCING PLANT LAYOUT

11. Should be planned in the objectives of :
Achieving minimum wastage of spaces
Achieving maximum ease of operations
The layouts should :
Make optimum utilization of floor space and height , Should be ventilated.
Should be 1.5-3m wide to facilitate traffic.
Permit effective and orderly segregation of various categories of materials and
allow rotation of stock. protected from waste, damage and deterioration.
Have provisions for storage as per specific conditions.
STORE LAYOUT

12. STORE LAYOUT

13. Lighting :
Adequate lighting shall be provide in all areas.
Ventilation ,air filtration, air heating and cooling.
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 system, including prefilters and particulate matter air filters , shall be
used appropriate on air supplies to production areas. Adequate ventilation shall be
provided.
SERVICES

14. Plumbing
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.
SERVICES

15. Washing and toilet facilities
Adequate washing facilities shall be provide ,including hot and cold water ,soap or
detergent , air drier or single –service towels , and clean toilet facilities easily
accessible to working areas.
SERVICES :

16. Manufacture ,processing ,packing ,or holding of a drug shall be maintained in a clean
and sanitary condition .
Any such building shall be free of infestation by rodents, birds , insects , and other
vermin.
Trash and organic waste matter shall be held and disposed of in a timely and sanitary
manner.
Sanitation procedures shall apply to work performed by contractors or temporary
employees as well as work performed by full-time employees during the ordinary
course of operations .
SANITATION

17. REFERENCE :-