(Rules and guidance for pharmaceutical manufacturers and distributors 2007, 2007)

 Pharmaceutical Press. (2007). Rules and guidance for pharmaceutical manufacturers and

distributors 2007 (p. 53). [London].

in recent project one of the prime design requirements is to create spaces and layouts that
.encourage staff to mix and communicate

)lay outs(

There are limits to the extent that buildings can promote interaction between staff. Cultural
factors in the organization are much more important than facility layout, but poor building
.layout can discourage or even prevent contact

layout constructed)

Interdiscipline and team interaction will occur in places where the social heirarchy imposed .
by the immediate workplace is removed, and, obviously, where people are brought together

personnal training)

Certain areas of the spaces will have air handling systems to provide air pressure cascades,
aimed at promoting containment, and exhaust air will be HEPA filtered for the same reasons

contamination)layout

Both during and after development there will be a requirement to manufacture batches for
clinical trials, to scale up the production process and provide ongoing support to
manufacturing technologies

cleanrooms and layout)

 (Tovey and Baker, 1999)

 Tovey, G. and Baker, R., 1999. Shaping the modern pharmaceutical development
facility. Pharmaceutical Science & Technology Today, 2(10), pp.409-413.

The flow of materials and personnel through the building or facilities should be
designed to prevent mix-ups or contamination. orange

Adequate, clean washing and toilet facilities should be provided for personnel. These
washing facilities should be equipped with hot and cold water as appropriate, soap or
detergent, air driers or single service towels. The washing and toilet facilities should
be separate from, but easily accessible to, manufacturing areas. Adequate facilities for
showering and/or changing clothes should be provided, when appropriate. 4.16
 (Rules and guidance for pharmaceutical manufacturers and distributors 2007, 2007)
 Pharmaceutical Press. (2007). Rules and guidance for pharmaceutical manufacturers and
distributors 2007 (p. 53). [London].

Laboratory areas/operations should normally be separated from production areas.

Some laboratory areas, in particular those used for in-process controls, can be located
in production areas, provided the operations of the production process do not
adversely affect the accuracy of the laboratory measurements, and the laboratory and
its operations do not adversely affect the production process or intermediate or API.
(contamination

Steps should be taken in order to prevent the entry of unauthorised people. Production,
storage and quality control areas should not be used as a right of way by personnel
who do not work in them.(contammination)

. 3(lay out)

Storage areas should be of sufficient capacity to allow orderly storage of the various
categories of materials and products: starting and packaging materials, intermediate,
bulk and finished products, products in quarantine, released, rejected, returned or
recalled. 3.19 Storage areas should be designed or adapted to ensure good storage
conditions. In particular, they should be clean and dry and maintained within
acceptable temperature limits. Where special storage conditions are required (e.g.
temperature, humidity) these should be provided, checked and monitored. 3.20(lay out
page55 orange)
. 3.25 Printed packaging materials are considered critical to the conformity of the
medicinal product and special attention should be paid to the safe and secure storage
of these materials.)zay okhtha el fo2ha

The word ‘design’ can be interpreted to mean different things to different people. For
the purpose of this book it will be defined as the preparation of drawing a plan or
preliminary sketch in the process of using an invention, and it follows then that
certain essential criteria must be fed into the design to ensure that it can be
confirmed(design blue 2)
 (Rules and guidance for pharmaceutical manufacturers and distributors 2007, 2007)
 Pharmaceutical Press. (2007). Rules and guidance for pharmaceutical manufacturers and
distributors 2007 (p. 53). [London].

 Collins, P. (2018). Chemical engineering and the culmination of quality by design in

pharmaceuticals. Aiche Journal, 64(5), 1502-1510. doi: 10.1002/aic.16154

 (Collins, 2018)

Equipment should be arranged so that the process flows smoothly from one step to the
next. Proper arrangement and proper access can reduce the number of operators that are
.needed to run the plant

)conclusion

Another important aspect of equipment arrangement is minimization of the possibility of

.cross-contamination

Clean-in-place (CIP) systems for vessels and piping are being installed more frequently than .
in the past

)‫ الهاند بوك‬contamination(