1.

0 OBJECTIVE:

To describe the procedure for access control in all GMP areas.

2.0 SCOPE:

This procedure is applicable to all GMP areas like Quality Assurance Documentation,
Quality Control, Production, Warehouse, Engineering departments of Dishman
Carbogen Amcis Limited, Bavla.

3.0 RESPONSIBILITY:
In-charge – : To ensure that any unauthorized person shall not have access
Respective to the respective GMP area and to update the list of authorized
Department person from time to time. The same concerned shall avail as
escort during any visitor’s entry.
Head – Concerned : To authorize entry of the external visitors as and when
department required.
4.0 APPROVALS:

5.0 DEFINITION:

6.0 Not Applicable

PROCEDURE:

6.1 Entry of visitors

NOTE: Security guards are posted at all the gates to the premises.
6.1.1 Visitors are allowed to enter from gate no. 1 only.
6.1.2 The security personnel collect the details of visitor like name, address, purpose of
visit, name of person to meet etc.
6.1.3 Inform the person whom the visitor wants to meet and get his/her consent for entry.
6.1.4 After getting consent, issue the visitor’s gate pass and visitor’s identity card to the
visitor and make entry in the visitor’s register & direct the visitor to the
administration building.
6.1.5 The personnel department representative then decides whether he/she should be
allowed to go inside to meet the person along with the representative from concerned
department or to arrange a meeting in the admin building.
6.2 Entry of materials
6.2.1 Any material inward and outward is from gate no. 2.
6.2.2 When any material arrives, the security supervisor at gate no.2 informs warehouse
personnel for confirmation of material inward.
6.2.3 After getting confirmation from warehouse dept., the security supervisor check the
 documents of material, physical checking of material as per the document and check
the vehicle.
6.2.4 Security supervisor issues a vehicle entry pass to permit the entry inside the factory
premise.
6.2.5 After unloading the material the driver of the vehicle gets the signature of warehouse
personnel on the entry pass and returns to gate no. 2.
6.3 Engineering Services
6.3.1 The engineering department enters the area if required after appropriate work permit
accompanied by the concerned department personnel.
6.4 A list for access to GMP areas is available with all areas & is approved by QA.

7.0 RECORDS:

7.1 None

8.0 ANNEXURES:

8.1 List of Authorized person (Annex – I)

9.0 REFERENCE:
9.1 In-house access control

10.0 ABBREVIATIONS AND DEFINITIONS (IF ANY):

QA : Quality assurance
QC : Quality Control
RA : Regulatory Affairs
Sr : Senior
GMP : Good Manufacturing Procedure
Asst : Assistant
no. : Number
11.0 HISTORY:
Revision no. Summary of change Effective date
01 Periodic Review May, 2011
02 Periodic Review 31st March, 2017
03 Company name has been changed 13th January, 2020
from Dishman Pharmaceuticals and
Chemicals Limited to Dishman
Carbogen Amcis Limited. Section
11.0 “History of Change” is revised
to maintain last three revision
history.
 Employee No. Name Department

Sign :

Date:
NOTE: All Auditor and Visitor shall accompany with QA representative.