1.0 Purpose
1.1 To define a standard entrance and exit procedure for all employees of the plant and visitors.
2.0 Scope
2.1 This Sop is applicable for all employees of "NAME" Pharmaceuticals Ltd. including visitors.
3.0 Responsibility
3.1 All employees of manufacturing unit of "NAME" Pharmaceuticals Ltd.
4.0 Abbreviations and Definitions
4.1 Not Appreciable
5.0
Materials
and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Not Appreciable
7.0 Procedure
7.1 Colour coding of uniform
Colour coding of the uniform are as follows:
White : All Officers, Managers including visitors
Green : Production Operator, Machine Helper,
Sky Blue : General Workers / Packer
Dark Blue : Engineering
Maroon : Warehouse Workers
Yellow : Cleaners
Orange : Canteen Workers
The pictorial diagram /display of entry & exit and gowning & de-gowning procedures are displayed in the change area.
7.2 Entrance procedure to the plant
7.2.1 Open the door and enter the first change room.
7.2.2 Remove personal shoe & clothes and keep in designated lockers.
7.2.3 Put on the sandals that are kept in shoe rack.
7.2.4 Open the door and enter washroom and wash hand, face, foot and shower, if necessary.
7.2.5 Enter the second change room and put off sandals & sit on the step over bench and cross the step over bench & wear the factory footwear provided in the racks.
7.2.6 Disinfect hand, using IPA (Isopropyl Alcohol) solution 70% or hand sanitizer provided in the Dispenser.
7.2.7 Wear the factory uniform (Apron, cap and mask) provided in the designated dress cabinet.
7.2.8 Check for proper gowning in the mirror provided. Gowning should match as per pictorial diagram / display.
7.2.9 After completion of gowning procedure, open the door and enter the corridor and go to the respective department.
7.3 Exit procedure from the plant
7.3.1 Enter in to respective second change room.
7.3.2 Put off internal uniform (Apron, cap and mask) and keep into the designated locker.
7.3.3 In case of person for primary manufacturing area, they drop the used shoes & all garments into the designated bin for washing.
7.3.4 Put off the disposable garments, shoe cover, etc to the waste bin.
7.3.5 Sit on the step over bench, put off internal shoes, and cross the step over bench.
7.3.6 Enter the first change room.
7.3.7 Wear the street / personal shoe & clothes/ dress.
7.3.8 Open the door and leave the first change room.
8.0 Reference Document
8.1 In-house
9.0
Annexure
9.1 Annexure-I : Pictorial Diagram of Entry
Procedure
9.2 Annexure-II : Pictorial Diagram of Exit
Procedure
10.0
Revision
History
|
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
|
02 |
|
|
|
11.0 Training
11.1 Head of Quality Assurance or his nominee give the training of all the employees.
