The ppt contains information about site and plant security and its guidelines in Quality assurance of any organization.

1. SITE AND PLANT
SECURITY
Presented by-
Vaishali V. Dudhabale
M Pharm F. Y. (Q.A.T.)
Guide-
Dr. Sonali Mahaparle

2.  INTRODUCTION:
 Site may be defined as a geographic location where one or more pharmaceutical plants are
situated and operated.
 Plant may be defined as a specific block or building on a site, engaged in the manufacturing
of pharmaceutical.
 Security-the state of being free from state of injury.
 Medical control council of south Africa (M.C.C.S.A.) provides guidelines for control on
following points:
1.Security personnel
2.Entry to site
3.Entry to building
4.Internal security Slide no. 1
Fig. plant image

3. 1. Security personnel
1. SECURITY MANAGER:
1. Should be appointed by the management.
2. Should be trained properly. Previous experience in police, defence services or
industrial security is essential.
3. A written job description, job profile and expectations.
4. Freedom to evaluate the security requirements and should be provided with resources
demanded by him.
2. SECURITY STAFF:
Sufficient staff, trained, defence and police experience is desirable. Plants should be
guarded on 24X7 basis.
Slide no. 2

4. 2.Entry to site
 Sites should restrict, entry of unauthorised persons.
Following safety measures may be used:
 A perimeter fence of good quality.
 Adequate security lighting.
 Limited & restricted access to the production and storage areas.
 Sufficient but limited no. of gates should be provided which should be lockable.
 Suitably armed security guards should patrol the grounds during day and night.
A total electronic sound alarm system may be provided.
 Security guards may be provided with trained security dogs. Slide no. 3

5. 3.Entry to plant buildings
1. The content of building is important for deciding the level of protection:
 Robust outside door,
 Good quality locks,
 Inaccessible windows,
 Installation of burglar alarms.
2. Consideration should be given to restricting and controlling entry to vital areas within
building where higher risk items are placed.
Slide no.4

6. 4. Internal security
 There should be an elaborate procedure for managing internal security of sites & plant.
 Locking of areas & storage of keys.
 “Restricted areas-for authorised person only”.
 Control on all unnecessary staff movement.
 Control over movement of customers and visitors.
 Control of movement of stock.
 Random physical checking of the inventories.
Slide no.5

7. .
 The checking of waste and checking of cleaning and security staff.
 Checking batch yield.
 The searching of staff on leaving the premise or other.
 Screening of staff on employment, including careful checking of
references.
 Attention on delivery services & other vehicles entering or leaving the
premises.
Slide no. 6

8.  Current issues
 Major issue is theft, while construction/ project stage.
Thefts of construction materials are common happenings. This should be
protected either by steel wires or by brick work. Normally this is done at the end of
the project.
A proper inventory and identification of items received must be kept at the site.
The use of R.F.I.D (Radio Frequency Identification) technique is now-a-days in
trend. RFID-tagged pharmaceuticals can be tracked through warehouses; and
implanting RFID microchips in livestock and pets allows for positive identification
of animals.
Slide no. 7
R.F.I.D. Chip

9.  Documents required
i. SOP on employment of security personnel and security manager.
ii. Job description of security guards and manager.
iii. SOP/Records of people entering site.
iv. SOP/Records of people entering plant.
v. SOP on management of internal security.
Slide no. 8

10.  References
 Book of Pharmaceutical quality assurance by Manohar A. Potdar, Nirali
prakashan, pg. no. 11.1-11.4 .
Slide no. 9

11. .
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