Premises
2. To list key requirements for site choice
3. To consider specific requirements for main areas
 
!-
Premises
Principle
!mportant aspects to "e kept in mind to ensure the suita"ility of
the operations to "e carried out for different dosage forms and
product range#
!-, !-.
+eigh"ours
What do they do? What impact can they have on the
business?
 
!-.
Premises
Principle
 
!-!
(inimie risks of errors
,ermit effective cleaning
,ermit effective maintenance
 'void any adverse effect on the quality of products  
 
Premises
 
12ample of Materials and People low  
 'rrival of goods ntrance for visitors ntrance for orkers Shipment of goods
(aterial low
  ,eople low
  5one# &lean
  5one# ,ackaging
  5one# &ontrolled
!-3, !-$, !-&
Premises
0esign
&leaning and disinfecting according to detailed written
procedures 6 records maintained
,rocedure for rodent and pest control
 
!-4, !-"!
Premises
5onstruction
Temperature and relative humidity control
 'ppropriate and effective ventilation
 
Basic Principles of GMP 
The temperature and relative
the results recorded. The
limits should "e appropriate
according to the materials
!-"
etc.)
(easures to facilitate cleaning
Basic Principles of GMP 
materials
!-6
Premises
Maintenance
&areful maintenance done
:epairs and maintenance should not present any haard to the
quality of the products
Basic Principles of GMP
!- 7 !-"6
slides 7,art 28#
!- 7 !-.
Premises
quality control areas
num"ers
possi"le 6 tools in reserved areas
 'nimal houses well isolated 6 separate air handling and
entrance
Basic Principles of GMP
' !:
Basic Principles of GMP
Basic Principles of GMP 
Basic Principles of GMP 
duster 
cleaner 
tunnels
!-3, !-6
9rderly storage of categories of materials and products
Separate and segregated areas# starting materials* packaging
materials* intermediates* "ulk* finished products* quarantined*
released* reected* returned and recalled products and
materials
Basic Principles of GMP 
Basic Principles of GMP 
!-6, !-$
Premises
defined limits
)ood storage conditions# clean* dry and appropriate lights
 
!-4 7 !-!%, !-!!
 ' separate sampling area is the norm# no risk for contamination
or cross/contamination
and products
 
Basic Principles of GMP 
!-!
Special attention to sampling
nsure compliance with specifications* prevent mi0/ups
 
!-!"
 'ppropriate design 7see also training material on =?'&8
,rovision for dust control
&leaning procedures and records
 
Basic Principles of GMP 
!-!.
 
!-"!, !-!6, !-"
Premises
 'ppropriate cleanliness level
minimies risk of contamination, mix!ups and missing  production steps
Specially designed areas for packaging
$ayout to avoid mi0/ups and cross/contamination
 
!-!$
Starting and packaging materials* intermediates and "ulk e0posed to environment#
"nterior surfaces #walls, floors, ceilings) $ smooth, free from cracks and open %oints
&o shedding of particles
%isinfection if needed
!-!4, !-!&
Premises
Production areas # .
%esign of pipework* light fittings* and ventilation points 6 no recesses that are difficult to clean
 'ccess for maintenance from outside production areas
%rains of adequate sie* and equipped to prevent "ack/flow
9pen channels avoided
Basic Principles of GMP
!-"%
ffective ventilation with air control facilities
!ncluding filtration of air to a sufficient level to prevent contamination and cross/contamination 6 also e0ternal environment
&ontrol of temperature and relative humidity where necessary
 
!-"", !-".
Separate areas for "iological* micro"iological and radioisotope methods
 
Basic Principles of GMP 
!-"3, !-"6
Separate air supply 7production and ;&8
Separate rooms for some instruments to protect them from interference 7e.g. electrical* vi"ration* moisture* etc.8
See supplementary training on ;& la"oratories